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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

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ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100071
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hematoma (1884)
Event Type  Injury  
Manufacturer Narrative
It is indicated that the product is not returning for evaluation.As the patient did not provide a lot number of the product used, testing using reserve product from the same lot and a manufacturing review could not be conducted.No further investigation is possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
 
Event Description
In (b)(6) of 2015, the patient stopped coumadin use to undergo a surgery to replace his urinary sphincter.After the procedure, the patient monitored his inr readings using the inratio system before resuming coumadin use.The patient alleged receiving a "false normal reading" using the inratio system.Post operatively, the patient developed a scrotal hematoma.The patient reported being on bed rest and in extreme pain for a few months.The patient then underwent surgery to remove the hematoma.After receiving the inratio system withdrawal notification on approximately (b)(6) 2016, the patient stopped use of the inratio system.No additional information was provided.
 
Manufacturer Narrative
Additional information: (age at time of the event) was updated to include the patient's date of birth.(describe event or problem) was updated to include the patient's therapeutic range.(other relevant history) was updated to include the patient's preexisting medical condition.(reported name and address) was updated to include an additional phone number.
 
Event Description
In (b)(6) of 2015, the patient stopped coumadin use to undergo a surgery to replace his urinary sphincter.After the procedure, the patient monitored his inr readings using the inratio system before resuming coumadin use.The patient alleged receiving a "false normal reading" using the inratio system.The patient's therapeutic range was 2.0-3.0.Post operatively, the patient developed a scrotal hematoma.The patient reported being on bed rest and in extreme pain for a few months.The patient then underwent surgery to remove the hematoma.After receiving the inratio system withdrawal notification on approximately (b)(6) 2016, the patient stopped use of the inratio system.No additional information was provided.
 
Manufacturer Narrative
(describe event or problem) updated to include information regarding medical records received 09/15/2017.
 
Event Description
In (b)(6) of 2015, the patient stopped coumadin use to undergo a surgery to replace his urinary sphincter.After the procedure, the patient monitored his inr readings using the inratio system before resuming coumadin use.The patient alleged receiving a "false normal reading" using the inratio system.Post operatively, the patient developed a scrotal hematoma.The patient reported being on bed rest and in extreme pain for a few months.The patient then underwent surgery to remove the hematoma.After receiving the inratio system withdrawal notification on approximately (b)(6) 2016, the patient stopped use of the inratio system.No additional information was provided.On 09/15/2017, extensive medical records were received regarding this event.The medical records describe the same event and no new complaint is alleged.There is no reported information that would alter the initial mdr reporting decision or mdr filed.
 
Manufacturer Narrative
On 11/17/2017, an executive summary and review of the patient's medical was received.The following sections have been updated to reflect the additional information: (describe event or problem) and (other relevant history) updated to include additional information.
 
Event Description
The patient saw his urologist on (b)(6) 2015 complaining that he had recently developed stress urinary incontinence that progressed to more continuous leakage to the extent he was wearing pads.An artificial urinary sphincter had been placed in 2009 to treat urinary incontinence that developed following prostate surgery and/or radiation for colon cancer.Medications included alprazolam 0.25 mg, amiodarone 200 mg, amlodipine 2.5 mg, aspirin 81 mg, benzonatate 100 mg, coq-10 100 mg, lisinopril 20 mg, synthroid 75 mcg, and tramadol 50 mg.The patient acknowledged sinus problems, incontinence, chest pain/palpitations/high blood pressure, abnormal bruising, ejaculation problems and infertility, frequent cough, and neck/back pain.Urinalysis was negative except for 0.2 urobilinogen.Prior lab work on (b)(6) 2015 including urinalysis, lipid studies, tsh, hemoglobin a1c, psa, cbc and blood chemistry were normal except total bilirubin was elevated at 1.4 (normal 0.3-1.0) and platelets were low at 135 (normal 150-440).Diagnosis was stress incontinence with urethral atrophy due to long term use of an artificial urinary sphincter.Surgery was planned to remove and replace the sphincter.The patient and his wife were taking a trip to eastern europe the following month and he expressed a desire to have the operation before then.The artificial urinary sphincter was replaced at (b)(6) hospital on (b)(6) 2015.Estimated blood loss was described as minimal.Hemostasis was good.After sufficient recovery from anesthesia, the patient was discharged home.The outpatient postoperative period was complicated by the development of a painful scrotal hematoma extending to the inguinal area and difficulty with urinary flow requiring straining.The patient reportedly had withheld coumadin for five days prior to the (b)(6) 2015 procedure, then resumed coumadin on (b)(6) 2015.He was readmitted to (b)(6) on (b)(6) 2015.Exam revealed significant suprapubic ecchymosis and swelling with significant tenderness.The hematoma appeared to extend to the right groin which was larger than the left.The scrotum was blackened.The perineal incision was healing with no drainage.Hemoglobin/hematocrit were 10.5/30.5 and platelets were 160.Ct confirmed the hematoma extended up the right groin but it did not enter the pelvic cavity.Diagnoses were scrotal hematoma secondary to anticoagulation, status post insertion of an artificial urinary sphincter, anticoagulation due to atrial fibrillation and aortic valve replacement, currently subtherapeutic, and mild voiding dysfunction.Ice, analgesia, iv antibiotics, and serial hematocrit levels were planned.Cardiology consultation was obtained on (b)(6) 2015.The patient stated he withheld coumadin for five days prior to the procedure, resumed coumadin on (b)(6) 2015, began developing groin pain and swelling, withheld coumadin on (b)(6) 2015, then was readmitted.He stated his blood thinners and history of abdominal radiation were not allowing healing.He admitted to paroxysmal nocturnal dyspnea, which he attributed to his sleep apnea.There was nausea but no vomiting, fever or chills.He denied any signs or symptoms of bleeding including hematuria, hematochezia, melena, nosebleeds or gum bleeding.He reported recent concentrated orange urine.Medications included amiodarone 100 mg monday/wednesday/friday, amlodipine, aspirin 81 mg, azithromycin, zyrtec, vitamin d3, voltaren prn, lovenox 80 mg subcu every 12 hours, flonase, folic acid, synthroid, lisinopril, nitroglycerin prn, prednisone, zantac, crestor, tramadol prn, ubiquinone, vitamin e, warfarin 4 mg tuesday/thursday/saturday/sunday, and 2 mg on the remaining days of the week.Hemoglobin/hematocrit were 8.1/23.8 on hospital day two with no active bleeding noted, and platelets were 153.Pt/inr were 15.9/1.51.(b)(6) 2015 ptt/heparin levels were 33.3/0.36 and urinalysis results included 0-3 rbcs/hpf.Coumadin was to remain on hold.Amiodarone and lovenox were to be continued, among other medications.The cardiologist said a heparin drip could be considered should lovenox need to be stopped for surgery.On (b)(6) 2015, cardiology noted the patient had received two units of packed red blood cells overnight.He was feeling less pain and pressure in his groin.An echocardiogram revealed a left ventricular ejection fraction of 61%, mildly dilated left atrium, mild aortic valve insufficiency, probably some inferior wall hypokinesis, mild tricuspid and mitral valve regurgitation, a dilated ascending aorta, and aortic valve replacement.He was deemed stable for discharge.Discharge medications included cipro and dilaudid.He was to follow up with urology.During his first outpatient postoperative visit on (b)(6) 2015, the scrotal hematoma was noted to be causing discomfort.Keflex was included in the list of medications.Other complaints included abdominal pain, nausea/vomiting, indigestion/heartburn, sinus problems, itching, palpitations/hypertension, abnormal bruising, problems with erections/ejaculation/infertility, and wheezing/frequent cough/shortness of breath.Urinalysis included a small amount of bilirubin, protein 30 mg, and 0.2 urobilinogen.The scrotal hematoma extended to the inguinal canals with ecchymosis in the upper thighs.It is described as less tense than during the hospital stay and was thought to be improving.He was given a prescription for hydromorphone and was to return in one week.On (b)(6) 2015, the patient is noted to be continuing on lovenox.Scrotal pain had improved significantly.He reported an unquantified low grade fever the prior evening.Hemoglobin was 9.Urinalysis results included 0.2 urobilinogen and a trace of leukocytes.He complained of fever and fatigue.The left inguinal hematoma was still firm, but less tense.He is described as improving.Augmentin was to be taken for the next 10 days and he was to return in 10-14 days.A hematologist was seen on (b)(6) 2015.He noted the patient had undergone several surgical procedures prior to 2004, but then had problems with bleeding since 2004.He said pt/ptt, factors ii, v, viii, ix, x, xi, xiii, von willebrand factor, and von willebrand activity were all normal.Fibrinogen activity was high at 521 (normal 200-400), and fibrinogen antigen was high at 609 (normal 180-350).Selected other study results include rbcs/hemoglobin/hematocrit with a low h&h at 4.16/12.3/37.3, and platelets were normal at 215 (normal 150-379).D-dimer was elevated at 1.06 (normal less than 0.50).He said the patient did not appear to have any intrinsic platelet problems, or an acquired or hereditary coagulopathy, and that bleeding was probably secondary to anticoagulation.The hematologist continued to monitor inr values and warfarin therapy.The patient returned to urology on (b)(6) 2015 stating he was found by a hematologist to have acquired von willebrand's factor deficiency.(this is in conflict with the hematology records described above, which indicate the patient does not have von willebrand's, but do acknowledge a history of a bleeding disorder dating back to 2004).The left inguinal region was still firm but less tense and mild erythema of the scrotal skin was noted.The hematoma was noted to be resolving.The patient had begun expressing some of the hematoma through the incision.There was some concern about infection but there was no fever and he was improving.He was to continue augmentin and return in two weeks.The hematoma continued to resolve and was greatly improved by (b)(6) 2015.The patient was to continue keflex during his european vacation.When the patient returned on (b)(6) 2015 he reported low-grade fever and generalized malaise that began a few days after he finished antibiotics.There was still some mild non-purulent drainage from the scrotum.The urologist was concerned about infection and wanted to evacuate the hematoma and irrigate with antibiotics or remove the entire system if it indeed looked infected, but noted the patient was on anticoagulants.He noted "he is seeing a hematologist at emory and we should have some resolution of this soon." augmentin was restarted twice daily.Platelet aggregation studies by hematology on (b)(6) 2015 were normal.The patient was readmitted to (b)(6) hospital (b)(6) 2015 for removal of the artificial urinary sphincter after he noted the sphincter eroding through the scrotum.Rbcs/hemoglobin/hematocrit were low at 4.26/12.2/36.2, and platelets were low at 127 (normal 140-420).Inr was 2.23 due to his history of coagulation disorders, hematology was consulted to manage anticoagulation.He was started on a heparin drip and thrombocytosis was noted.On (b)(6) 2015 rbcs/hemoglobin/hematocrit levels showed h&h low at 4.33/12.3/37.0 and platelets were low at 115.Inr was 1.9.Heparin was advanced.Pt/ptt/inr on (b)(6) 2015 were 15.8/49.9/1.48.Heparin was to be held for six hours prior to surgery to remove the urinary sphincter device, which was performed (b)(6) 2015.Anticoagulation was resumed and managed by hematology.On (b)(6) 2015 pt/ptt/inr were 12.4/30.4/1.18.A (b)(6) 2015 test for heparin-induced thrombocytopenia was negative.He developed gross hematuria on (b)(6) 2015 that resolved the same day, and he was deemed stable for discharge.On (b)(6) 2015, the patient reported having a sharp twinge in the left inguinal region while reaching, followed by acute swelling in the left scrotum which then stabilized over the prior two days.There was a small hematoma.He was to return in two to three weeks.The patient reported only mild incontinence and mild left inguinal pain on (b)(6) 2015.He was taking augmentin.He was to return in three months.By (b)(6) 2015 he is noted to be doing well after removal of the urinary sphincter with only some mild testicular discomfort and only a small amount of urine leakage with stress maneuvers.He was placed on a trial of cymbalta for urinary leakage and was to return in six months.On (b)(6) 2016 the patient reported improvement in mild stress urinary incontinence with cymbalta and said he didn't find the leakage to be bothersome.He said he had been doing great.He had mild left flank pain that felt like a kidney stone so a kub study was planned.He was to return in six months.After receiving the inratio system withdrawal notification on approximately (b)(6) 2016, the patient stopped use of the inratio system.
 
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Brand Name
INRATIO PT/INR TEST STRIPS
Type of Device
PROTHROMBIN TIME TEST
Manufacturer (Section D)
ALERE SAN DIEGO, INC
9975 summers ridge road
san diego CA 92121
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key6444315
MDR Text Key71202163
Report Number2027969-2017-00059
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number100071
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-2354,2362-2016
Patient Sequence Number1
Treatment
INRATIO2 MONITOR, PN 200432, SERIAL# UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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