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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; High Test Results; Device Displays Incorrect Message
Event Date 07/31/2015
Event Type  Malfunction  
Manufacturer Narrative

Investigation pending.

 
Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab/poc inr result. The results were as follows; (b)(6) unsure if lab or poc=4. 8, (b)(6) inratio=4. 0, (b)(6) inratio=1. 4, (b)(6) lab=2. 7. Patient self tester's therapeutic range: 2. 0-3. 0. The patient self tester went to the physician's office on (b)(6) and had his inr tested, inr=4. 8. Wife was unsure if the result was obtained through a poc meter or a laboratory method. No dosage changes were made because the physician did not agree with the result. On (b)(6) patient tested on his monitor with result of inratio inr=4. 0. This result was reported to physician and dosage was changed. Testing was done on (b)(6) with inratio=1. 4; physician had patient self tester increase dosage however wife does not remember how much of an increase. On (b)(6) the patient self tester attempted to retest again and received 2 error messages (for not enough sample); no dosage changes were made. On (b)(6) a lab test was performed with an inr=2. 7. Using the venous blood testing was done on the inratio monitor with qc2h error message.

 
Manufacturer Narrative

It is indicated that the product is not returning for evaluation. Therefore, a review of the in-house testing history was performed. In-house testing on strip lot 369157a met release criteria. The product performed as expected. A review of the manufacturing records for lot# 369157a did not uncover any non-conformances. The lot met release specifications. Root cause could not be determined from the information provided 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 Key5057773
Report Number2027969-2015-00650
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number100071
Device LOT Number369157A
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 Received12/20/2015
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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