MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Hematuria (2558)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between inratio inr results and the lab inr results.The results were as follows: inratio 2.2; lab 6.5.Physician reports (via distributor) a discrepant low result with one patient on (b)(6) 2015.A patient in (b)(6) visits physician because of blood in his urine.The inratio shows inr = 2.2.The patient is referred to a urologist who refers patient to the hospital.Hospital's lab tests inr = 6.5, the time between the two tests is about four hours.Nurse states that the patient had stable values prior to this time.The patient was hospitalized due to blood in the urine.A follow up call was made with the specialist, dr.(b)(6).The physician stated that the patient is doing well.The preliminary medical report from the hospital does not provide any other medical reason for the bleeding except the elevated inr.The general practitioner will perform inr measurements for this particular patient only in the lab.The specialist, dr.(b)(6) is considering switching the patient's medication over to a doac (direct oral anticoagulant).No further information is available concerning the length of time patient was in the hospital, what treatments he received or what his inr values were.All other comparative measurements of other patients were acceptable.

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Therefore, in-house testing with the reported lot was performed.In-house testing on strip lot k377620 meets criteria.The product performed as expected.A review of the manufacturing records for lot k377620 did not uncover any non-conformances.Root cause cannot be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL 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: 5349222
• MDR Text Key: 35214300
• Report Number: 2027969-2016-00010
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99008G1
• Device Lot Number: K377620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization