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	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2023, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a positive results on a 12 year old female patient with sickle cell.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date tested result sample i-stat, (b)(6)2023, 1214, 373 iu/l, a.Roche, (b)(6)2023, 1218, <1 iu/l , b.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.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.
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 14-dec-2023.Retained cartridge testing could not be performed as the lot expired on 09-apr-2023, prior to the investigation initiation date of 10-nov-2023.Although previous retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure), total b-hcg cartridge lot p22297 is associated with a previously identified deficiency unrelated to the customer's observation of a high discrepant result.The deficiency is addressed by quality record 904333.

• 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: 18131470
• Report Number: 2245578-2023-00162
• Device Sequence Number: 7753240
• Product Code: DHA
• UDI-Device Identifier: 10054749001009
• UDI-Public: 10054749001009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/19/2023

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: 04/09/2023
• Device Catalogue Number: 05P58-25
• Device Lot Number: P22297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: 12 YR
• Patient Sex: Female