I-STAT B-HCG CARTRIDGE 05P58-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.

Event Text Entries

[54077407] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[54077408] On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result of 318. 8 on a (b)(6) female patient with abdominal pain. The patient was admitted to rule out ectopic pregnancy. The test was repeated on an alternate method and the result was <1 based on the information available. An ultrasound concluded that patient was not pregnant. There was no additional patient information at the time of this report. The customer states that return product is available for investigation. Method: / date:/ time:/ result: i-stat / (b)(6) 2016/ 1901/ 318. 8 iu/l. Dimension/ (b)(6) 2016/ 1456/ <1. 0 miu/ml. There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5


[55702392] Apoc incident # (b)(4). The investigation was completed on 09/13/2016. Customer returns and retain product was tested and are functioning according to specification.
Patient Sequence No: 1, Text Type: N, H10


[55702393] Na
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2245578-2016-00090
MDR Report Key5906001
Date Received2016-08-26
Date of Report2016-09-19
Date of Event2016-08-09
Date Mfgr Received2016-09-13
Device Manufacturer Date2016-04-27
Date Added to Maude2016-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA MACZUSZENKO
Manufacturer Street400 COLLEGE ROAD
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6136885949
Manufacturer G1ABBOTT POINT OF CARE CANADA LTD.
Manufacturer Street185 CORKSTOWN ROAD
Manufacturer CityOTTAWA, ONTARIO K2H 8V4
Manufacturer CountryCA
Manufacturer Postal CodeK2H 8V4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-STAT B-HCG CARTRIDGE
Generic NameB-HCG CARTRIDGE
Product CodeNAL
Date Received2016-08-26
Returned To Mfg2016-08-18
Model NumberNA
Catalog Number05P58-25
Lot NumberA16118
Device Expiration Date2016-09-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.