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 Codes	Abdominal Pain (1685); Diarrhea (1811); Nausea (1970)
Date of Event	03/13/2022
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 19-jan-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a positive result on a 39 year old female patient with abdominal pain, nausea, diarrhea.There was no additional patient information at the time of this report.Return product is not available for investigation.Method; date; collected; tested & result.I-stat, (b)(6) 2022, 2:03pm, 2:14pm & 52.6 iu/ml.Roche, (b)(6) 2022, ni, ni & <5.0 iu/ml.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 26-apr-2024.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Retained cartridges could not be tested as the lot expired on 07-jul-2022, prior to the communication of the issue by the customer on 19-jan-2024.No deficiency has been identified for total b-hcg cartridge lot n22021b.

• 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: 18702697
• Report Number: 2245578-2024-00039
• Device Sequence Number: 6195087
• Product Code: DHA
• UDI-Device Identifier: 10054749001009
• UDI-Public: 10054749001009
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 07/07/2022
• Device Catalogue Number: 05P58-25
• Device Lot Number: N22021B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: 39 YR
• Patient Sex: Female