FDA Adverse Event Injury Summary report: N

TRIAGE PROFILER SOB 25 TEST KIT

MDR report key: 2193336 · Received July 28, 2011

Report

Report Number: 2027969-2011-01673
Event Type: Injury
Date Received: July 28, 2011
Date of Event: June 28, 2011
Report Date: July 28, 2011
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: NBC
PMA / PMN Number: K042723
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT SUPPORT TESTED CAL H (POS CTRL) AND CAL Z (NEG CTRL) ON SOB LOT W48946. OBSERVATIONS WERE FOR TNI RECOVERY. NO HIGH BIAS OR FALSE POSITIVE RESULTS WERE OBSERVED WITH ANY SAMPLE. CUSTOMER DID NOT RETURN ANY SAMPLE FOR FURTHER TESTING. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE THAT MAY HAVE AFFECTED ANALYTE RECOVERY. ALL RESULTS FOR TNI GIVEN BY CUSTOMER ARE BELOW THE CLINICAL CUTOFF OF 0.40NG/ML AS STATED IN THE PACKAGE INSERT. NO PRODUCT DEFICIENCY WAS ESTABLISHED. AS OF (B)(6) 2011 THERE ARE 3 COMPLAINTS FOR SOB LOT W48946. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

Description of Event or Problem · 1

CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS USING THE TRIAGE PROFILER SOB. PT F: PT WENT FOR AN URGENT CARDIAC CATHETERIZATION WITH NORMAL CORONARIES. CT CHEST SHOWED NO PULMONARY EMBOLISM. CARDIAC ECHOCARDIOGRAM WAS WITHIN NORMAL LIMITS. DISCHARGED (B)(6) 2011 WITH DIABETES MELLITUS, HYPOTHYROIDISM, HYPERTENSION, DEPRESSION AND ATYPICAL CHEST PAIN. THE FOLLOWING CUT OFF'S WERE USED: TNI: 0.01-0.05-BORDERLINE. NTPRO BNP: >450 (50Y) >900 (50-76Y) >1800 (>76Y). CK: 20-200, CKMB: 02.-2.4, DDIM: 0-400.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRIAGE PROFILER SOB 25 TEST KIT	CARDIAC MARKER TEST	NBC	ALERE SAN DIEGO, INC.	97300	W48946B

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization