FDA.reportPublic FDA data

MAUDE MDR 5652419

MDR report key
5652419
Report number
2245578-2016-00027
Event key
0
Event type
3
Date of event
2016-04-30
Date received
2016-05-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LINDA MACZUSZENKO
Address
400 COLLEGE ROAD PRINCETON NJ 08540 US
Phone
613-613-6136
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1I-STAT B-HCG CARTRIDGEB-HCG CARTRIDGEABBOTT POINT OF CARENALNA05P58-25A15352Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-130

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

ON (B)(6) 2016, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A SUSPECTED FALSE POSITIVE RESULT ON A (B)(6) PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE PATIENT WAS GIVEN A TRANSVAGINAL ULTRASOUND, WHICH CONFIRMED THE PATIENT WAS NOT PREGNANT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE, METHOD, SAMPLE, SAMPLE TIME, RESULT TIME, RESULT: (B)(6) 2016, I-STAT, A , 1505, 1507, >2000; (B)(6) 2016, SIEMENS, A, 1505, 1511, 2000; (B)(6) 2016, ALERE, URINE, 1457, 1701, NEGATIVE. BASED ON THE INFORMATION AVAILABLE AND INTERNAL CONTROL ALGORITHMS THE EVENT IS REPORTABLE AS A POTENTIAL PRODUCT MALFUNCTION ALTHOUGH NOT CONFIRMED AT THIS TIME. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

N

Patient 1

(B)(4). THE INVESTIGATION WAS COMPLETED ON 05/18/2016. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

D

Patient 1

NA