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

Catalog Number 05P58-25

Device Problem False Positive Result (1227)

Patient Problems Memory Loss/Impairment (1958); Nausea (1970); Dysphasia (2195); Numbness (2415); Hallucination (4428)

Event Date 08/11/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.

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 Description

Na.

• 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
• 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
• MDR Text Key: 336284373
• Report Number: 2245578-2024-00038
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female