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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274); Test Result (2695)

Event Date 03/03/2015

Event Type  Injury  

Event Description

"caller alleged discrepant results compared with the lab.Results as follows:" date: inratio: lab: (b)(6) 2015, ---, 9.0.(b)(6) 2015, --- , 7.4.(b)(6) 2015, 2.5 , ---.Patient self tester's therapeutic range is: 2.5-3.5.Patient self tester (pst) initially went to the hospital on (b)(6) 2015 for a check up on another admission that occurred three weeks prior for unspecified bleeding.It was discovered at that time that his hgb had dropped to around 4 something (exact value not available).The pst was given 6 unites of blood and was discharge three days later after determining bleed was due to small ulcers in his esophagus.Pst was admitted to the hospital on (b)(6) 2015 due to inr reading of 9.0 and was discharged on (b)(6) 2015.Pst had blood transfusions (including fresh frozen plasma) but confirmed no other treatments were provided.A repeat lab inr=7.4 was obtained on (b)(6) 2015; the following day inratio=2.5.Pst's warfarin was held between (b)(6) 2015 and dosage resumed on (b)(6) 2015.The next inr result was a lab result of 3.7 on (b)(6) 2015.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

The products associated with the complaint were returned for investigation.The customer's complaint of discrepant low results was not confirmed during in-house testing.Retain and return strip testing on the returned meter met both accuracy and strip repeatability criteria.The returned meter met functional and thermistor testing requirements during investigation.A review of the manufacturing records for the strip lot did not uncover any non-conformances.The lot meets release specification.The impedance curve analysis associated with the customer's inratio inr result of 2.5 found that the curve exhibited a weak slope change.Our capa investigation (b)(4) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.The patient had prostate cancer and anemia with a hematocrit of 9.1% at the time of the alleged discrepant result.Capa (b)(4) has identified hospitalized or advanced stage cancer and anemia with hematocrit less than 30% both as conditions that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause for the complaint is the patient having the conditions of prostate cancer and anemia with a hematocrit of 9.1% which may have contributed to an impedance curve that exhibited a weak-slope change.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.Further investigation is being performed under capa (b)(4).

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4625053
• MDR Text Key: 19810448
• Report Number: 2027969-2015-00207
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 348355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FUROSEMIDE; ATENELOL; ASPIRIN; INRATIO MONITOR SN: (B)(4); WARFARIN; ATORVASTATIN; OMEPRAZOLE; BICALUTIMIDE; LISINOPRI; IRON
• Patient Outcome(s): Hospitalization; Required Intervention