I-STAT B-HCG CARTRIDGE
Received May 13, 2016 · Event occurred Apr 13, 2016
Report 2245578-2016-00024 · MDR key 5652748
Device
Generic name
B-hcg Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
05P58-25
Lot number
A15337
Product problems
- False Positive Result
Patient
19 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
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) YEAR OLD FEMALE PATIENT ADMITTED WITH DIABETIC FLU LIKE SYMPTOMS. 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 AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2016, TIME: 21:12, I-STAT : 44, LAB: <1. 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.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 06/22/2016. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.
Description of Event or Problem
NA