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

Catalog Number	05P58-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4) apoc labeling was evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 27-mar-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a positive result on a 13 year old female patient with osteogenesis imperfecta.There was no additional patient information at the time of this report.Return product is available for investigation.Method date tested results sample i-stat (b)(6) 2024 09:26 30.3 1 i-stat (b)(6) 2024 09:50 23.7 2 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.The investigation is underway.I-stat positive cut-off values: b-hcg < 5.0 iu/l negative 5.0 < ss-hcg < 25.0 iu/l indeterminate b-hcg >25.0 iu/l positive intended use: the i-stat® total beta-human chorionic gonadotropin (b-hcg) test is an in vitro diagnostic test for the quantitative and qualitative determination of b-hcg in venous whole blood or plasma samples using the i-stat 1 analyzer systems.The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 29-apr-2024.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.An (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for total b-hcg cartridge lot f23311a.

• Brand Name: I-STAT B-HCG CARTRIDGE
• Common Device Name: B-HCG CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136123525
• MDR Report Key: 19023292
• Report Number: 2245578-2024-00071
• Device Sequence Number: 17113852
• Product Code: DHA
• UDI-Device Identifier: 10054749001009
• UDI-Public: 10054749001009
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K133002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Catalogue Number: 05P58-25
• Device Lot Number: F23311A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female