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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; Low Test Results; Device Displays Incorrect Message
Event Date 12/01/2015
Event Type  Malfunction  
Manufacturer Narrative

Investigation is pending.

 
Event Description

The end user's caregiver called to report a variance between the inratio inr result and the laboratory inr result. On (b)(6) 2015, the caregiver called after receiving 8 unspecified error messages on the inratio device. On the 9th test, the inratio inr was 1. 6. The following day, (b)(6) 2015, the patient went to a follow up radiation appointment and the laboratory inr was 2. 1. The patient has advanced stage cancer. Therapeutic range: 2. 0 - 3. 0. Reportedly, multiple fingersticks were performed on the same finger, the sample was not immediately applied, multiple drops of blood was applied and the finger touched the sample well. These are all considered to be improper techniques when performing the inratio test. There was no reported adverse patient sequela. There was no additional information provided.

 
Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation. Therefore, a review of the entire in-house testing history of the lot was performed. In-house strip testing on the reported strip lot met accuracy criteria and the product performed as expected. The customer's complaint was not replicated. The manufacturing records for the lot were reviewed and the lot met release specifications. Although the root cause analysis did not include return testing, improper techniques were identified in the complaint. These could not be ruled out as a cause of the unexpected results. The customer was reported to have advanced stage cancer. This condition may impact the performance of the assay. Based on the information available, there is no indication of a product deficiency and no corrective action is required.

 
Event Description

Clarification: the call was received on (b)(6) 2015 and the inratio error messages and the inratio inr result was performed on (b)(6) 2015.

 
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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 Key5299685
Report Number2027969-2015-01013
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type DISTRIBUTOR,OTHER
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number100071
Device LOT Number370763AR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2016
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 Unkown

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