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	Memory Loss/Impairment (1958); Nausea (1970); Dysphasia (2195); Numbness (2415); Hallucination (4428)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
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 27 year old female patient with dysphasia, slurred speech, nausea, memory loss, numbness, confusion, hallucinations.There was no additional patient information at the time of this report.Return product is not available for investigation.Method; date; collected; tested & result(iu/ml).I-stat, (b)(6) 2023, 07:22pm, 07:34pm & 63.6.Roche, (b)(6) 2023, ni, ni & <5.0.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).Apoc labeling was evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 25-apr-2024.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Retained 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 m23176.
Event or Problem Description
Na.

• 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: 18702677
• Report Number: 2245578-2024-00038
• Device Sequence Number: 6194560
• 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: 12/09/2023
• Device Catalogue Number: 05P58-25
• Device Lot Number: M23176
• 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: 04/25/2024
• 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: 06/25/2023
• 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: 27 YR
• Patient Sex: Female