FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 1849749 · Received September 27, 2010

Report

Report Number: 2027969-2010-01580
Event Type: Malfunction
Date Received: September 27, 2010
Date of Event: August 25, 2010
Report Date: September 27, 2010
Manufacturer: ALERE SAN DIEGO, INC
Product Code: GJS
PMA / PMN Number: 021923
Removal / Correction Number: NI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. INRATIO: 1.3; REFERENCE: 2.3; MEAN: 1.80; CONFIDENCE LIMITS: 1.2-2.3. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON MEET ACCURACY CRITERIA. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION WILL BE PURSUED. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. AS OF 09/27/2010, ELEVEN DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 1.3; LAB: 2.3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	233708

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI