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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST

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ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST Back to Search Results
Model Number 200432
Device Problems Nonstandard device; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Or Inadequate Test Results; Low Test Results
Event Date 08/24/2015
Event Type  Injury  
Manufacturer Narrative

Investigation is pending.

 
Event Description

The caller alleged a variance between the inratio inr results and the laboratory inr result. Results are as follows: date: inratio2 inr: laboratory inr: (b)(6) 2015, 1. 8, n/a; (b)(6) 2015, 3. 1, 7. 05; therapeutic range: 2. 0 - 3. 0. On (b)(6) 2015, there was no jantoven dosage change since the patient and the physician felt that the result was inaccurate. On (b)(6) 2015, the testing was performed consecutively. The patient's jantoven dose was held from (b)(6) 2015. There was no additional information provided.

 
Manufacturer Narrative

Investigation/conclusion: the monitor and remaining test strips associated with the complaint was returned for investigation. The customer's complaint was not confirmed during in-house testing. Returned and retained strips tested on the returned monitor met accuracy criteria. The testing history for lot 372984a was reviewed and the lot met release specification. The manufacturing records for the lot were reviewed and the lot met release specifications. The product performed as expected. The returned monitor passed functional and thermistor testing requirements during in-house investigation. The impedance curve associated with the customer's inratio inr result of 1. 8 was analyzed statistically and determined to be normal in shape. The impedance curve associated with the customer's inratio inr result of 3. 1 was also analyzed statistically and was determined to possess a weak slope change. Capa investigation (capa (b)(4)) has determined that impedance curves with weak slope change can cause discrepant results. It was also determined that certain patient conditions can contribute to weak slope change impedance curves. The customer had rheumatoid arthritis at the time of the alleged discrepant result. Capa (b)(4) has identified conditions associated with chronic inflammation as those that may contribute to discrepant inr results. A notification letter has been sent to customers to inform them of these patient conditions. A possible root cause is that the patient condition of rheumatoid arthritis may have contributed to an impedance curve that exhibited a weak-slope change. The inratio monitor software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve. Further investigation performed under capa (b)(4).

 
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Brand NameINRATIO2 PT MONITORING SYSTEM
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 Key5104554
Report Number2027969-2015-00705
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type OTHER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number200432
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0880, 0881, 0882-2015

Patient TREATMENT DATA
Date Received: 09/25/2015 Patient Sequence Number: 1
Treatment
JANTOVEN
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