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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 200433
Device Problems Nonstandard device; Device Displays Incorrect Message ; Human-Device Interface Problem
Event Date 06/23/2015
Event Type  Injury  
Event Description

A customer in (b)(6) reported that a new patient, who had just started taking warfarin for about a week (doses varied), received qc2h error messages on the inratio2 monitor. In an effort to obtain more information, alere followed up with the distributor. The following was reported: the hospital staff is familiar with inratio test strips and instructions for use. This error was only occurring when testing was performed on this one particular patient. This patient had thyroid problems and was receiving liver medications. The same monitor was used on other patients with acceptable results. On subsequent follow ups alere was notified that there were two valid inratio results, a 1. 3 and a 1. 5 inr obtained after the patient's dosage was reduced due to a misinterpretation of the qc2h error message. The following day the lab inr was 1. 18. Alere was also notified that the patient died on (b)(6) 2015 of heart failure. Although requested, the death certificate was not provided.

 
Manufacturer Narrative

Investigation pending.

 
Manufacturer Narrative

The customer reported receiving qc2 hi errors during testing. Qc errors are designed to be a failsafe error to prevent the reporting of erroneous results. These can be caused by multiple issues, including improper storage, technique issues, and sample interference. In-house testing using retain strips was performed. In-house testing did not produce customer's observation of qc2 hi errors. The monitor associated with this case was returned for investigation. The monitor memory was reviewed and found the possible results reported by the customer. An impedance curve analysis could not be performed on the results of 1. 3 and 1. 5 because they were not within the four (4) most recent results. The inratio 2 monitor is only able to store the impedance curve data for the four most recent results. The manufacturing records for the lot were reviewed. The lot met specifications and no non-conformances were documented. The certificate of analysis for the master lot was reviewed and found that qc errors were below the release specification. It was reported that the customer changed dosage based on the qc error. Changes in medicine dosages are not to be based on qc errors. 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 NameINRATIO2 PT MONITORING SYSTEM
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 Key4966005
Report Number2027969-2015-00534
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type Foreign,Health Professional,FOREIGN,HEALTH PROFESSI
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number200433
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/04/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2015
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 Unkown
Removal/Correction NumberZ-0880, 0881, 0882-2015

Patient TREATMENT DATA
Date Received: 08/04/2015 Patient Sequence Number: 1
Treatment
INRATIO PT/INR TEST STRIPS PN: 100071, LN: 366393
DIGOXIN
METHIMAZOLE (MERCAPTIZOL)
FUROSEMIDE
WARFARIN
SPIRONOLACTONE (ALDACTONE)
FERROUS IRON / FOLIC ACID
OXAZEPAM
DIPYRONE
OMEPRAZOLE
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