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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 Problems Improper or Incorrect Procedure or Method; Incorrect Or Inadequate Test Results; Expiration Date Error
Event Date 08/17/2015
Event Type  Malfunction  
Manufacturer Narrative

Investigation pending.

 
Event Description

The caller alleged a variance between inratio inr results. The results were as follows: (b)(6) inratio=1. 7; no dosage change, (b)(6) inratio=1. 8; no dosage change. Previous inratio result: (b)(6) inratio=2. 6. Patient self tester's therapeutic range is: 2. 5-3. 5. It was noted that the patient self tester is using expired strips.

 
Manufacturer Narrative

It is indicated that the product is not returning for evaluation. Therefore, a review in-house testing was performed. In-house strip testing on strip lot 332831 had met criteria. The product performed as expected. A review of the manufacturing records for the lot did not uncover any relevant non-conformances. Lot meets release specification. The customer was using expired strips. This may have contributed to the unexpected results experienced by the customer. Based on the information available, there is no indication of a product deficiency. No corrective action is required at this time.

 
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Brand NameINRATIO PT/INR TEST STRIPS
Type of DevicePROTHROMBIN 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 Key5119751
Report Number2027969-2015-00823
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 09/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number100071
Device LOT Number332831
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2015
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 Unkown

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