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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 Incorrect Or Inadequate Test Results; Device Displays Incorrect Message ; Human-Device Interface Problem
Event Date 10/01/2015
Event Type  Malfunction  
Manufacturer Narrative

Investigation is pending.

 
Event Description

The caller alleged low iinratio inr results. Results are as follows: date: (b)(6) 2015, inration inr: 3. 0 (no changes to the warfarin dose. ) (b)(6) 2015, 1. 4 and 1. 8 (20 minutes between testing). The caller did not believe that her inr was that low so she waited and retested but received an error message. Therapeutic range: 2. 0 - 3. 0. The caller reported that she has difficulty getting a large drop of blood quickly and getting the blood to drop onto the testing strip. There was no medication changes due to these unexpected low results and was instructed by her physician to retest in 2 weeks once the shingles medication is out of her system. On (b)(6) 2015, the caller's inratio inr result was 2. 9. There was no reported adverse patient sequela. There was no additional information provided.

 
Manufacturer Narrative

Investigation/conclusion: the customer did not provide any reference values for comparison. The accuracy of the customer's inratio results cannot be determined without this information. It is indicated that the product is not returning for evaluation. Therefore, a review of in-house testing was performed. In-house testing on strip lot 357499 met release criteria. The product performed as expected. Although a relevant nc was noted in the batch record, it did not affect the final release specifications. There is no indication of a product deficiency and additional corrective actions were not required. The customer was reported to have shingles. This condition may impact the performance of the assay. 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.

 
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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 road
san diego CA 92121
Manufacturer (Section G)
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 Key5167602
Report Number2027969-2015-00868
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number100071
Device LOT Number357499
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 Received10/26/2015
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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