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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Hematoma (1884); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The caller, patient's wife, alleged a variance between the inratio inr result in comparison to the poc inr results.The results were as follows: (b)(6) inratio inr=3.0.(b)(6) alternate poc inr=5.9, repeat 6.1.The patient self tester's therapeutic range is: 2.0-3.0.Other information provided by the patient self tester's wife, (b)(6): (b)(6) patient self tester (pst) injured leg on car door which created a hematoma.Pst taking antibiotics and pain medication.(b)(6) thinks last dose of antibiotics was week of (b)(6) however, cannot confirm.(b)(6) inratio = 3.0.(b)(6) pst given normal warfarin dose (6mg/day).(b)(6) and (b)(6) - withheld warfarin due to scheduled surgery.(b)(6) (b)(6) hospital - alternate poc = 5.9, repeat 6.1 (5 minutes, different hand).(b)(6) drs office alternate poc = 5.9 (b)(6) withheld warfarin due to alternate poc result.(b)(6) cataract surgery delayed due to inr result.No additional inratio results.(b)(6) pst admitted to hospital due to exacerbation of injury on leg.(b)(6) withheld warfarin dose.Inr in hospital.Dates and results unknown.(b)(6) hospital inr lab = 1.9 warfarin dose=5mg/day.(b)(6) warfarin dose=5mg/day.(b)(6) pst relocated to nursing home for care due to infection in wound.Pst started antibiotics.No inratio testing during this time.

Manufacturer Narrative

Conclusion: it is indicated that product is not returning for evaluation.Therefore, a review in-house testing was performed.In-house strip testing on the reported strip lot had met criteria.The product performed as expected.Although relevant non-conformances were noted in the batch record, they did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.Although improper techniques were identified in the complaint, 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.

Event Description

It was noted that the patient self tester was milking the finger after the fingerstick and touching finger to sample well when applying sample.

• 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: 5030240
• MDR Text Key: 24045547
• Report Number: 2027969-2015-00623
• 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
• Report Date: 07/29/2015

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: 365984A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• 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): Required Intervention