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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(6).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 a positive result of 1018.1 iu/l on a (b)(6) year old female patient (b)(6).There was no additional patient information at the time of this report.Return product is available for investigation.Method date collected tested results sample: i-stat (b)(6) 2020 17:55 17:58 1018.1 iu/l a, lab (b)(6) 2020 17:55 18:00 <1.0 iu/l a.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 11-mar-2021.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retains and returns cartridge testing met the acceptance outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for total b-hcg cartridge lot a20295.

• 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 08540 6607
• MDR Report Key: 10935628
• MDR Text Key: 241233872
• Report Number: 2245578-2020-00127
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Catalogue Number: 05P58-25
• Device Lot Number: A20295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR