MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT B-HCG CARTRIDGE

Catalog Number 05P58-25

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2020, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded two positive results of 38 & 27, along with a result in the indeterminate range on a female patient.There was no additional patient information at the time of this report.The customer stated that the patient sample was sent to the lab and confirmed patient is not pregnant.Return product is available for investigation.(b)(6).Collection times not provided.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.It is suspected that the positive results on i-stat are potentially related to a heterophilic antibody but unconfirmed at this time.The customer states the patient is not pregnant.The investigation is underway.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 04/06/2020.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ae (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for b-hcg cartridge lot n19311.

• Brand Name: I-STAT B-HCG CARTRIDGE
• Type of Device: B-HCG CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 9751410
• MDR Text Key: 198907697
• Report Number: 2245578-2020-00033
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 10054749001009
• UDI-Public: 10054749001009
• Combination Product (y/n): N
• PMA/PMN Number: K133002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: 05P58-25
• Device Lot Number: N19311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability