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 Fever (1858); Nausea (1970); Sepsis (2067); Vomiting (2144); Weakness (2145); Dyskinesia (2363)

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a positive result of 79.4 on a (b)(6) female patient with the clinical symptoms presented as nausea/vomiting, fever, sepsis, and biliary dyskinesia.Initially the customer stated that patient was pregnant.However, on (b)(6) 2019 the customer stated that the patient was not pregnant.Therefore rendering the i-stat results as a false positive.The customer further reported that patient had expired on (b)(6) 2019 at 0:33 hours.The cause of death is unknown but the customer confirmed that the i-stat result did cause or contributed to the patient's demise.There was no additional patient information.Return product is not available.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.It is suspected that the positive results on i-stat are potentially related to a heterophilic antibody but unconfirmed at this time.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Event Description

Na.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 02/06/2019.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ss-hcg cartridge lot f18325.Date of report: from 1/16/2019 to 1/31/2019.Justification: apoc was contacted on 01/31/2019 the customer stated that the patient was not pregnant.Therefore rendering the i-stat results as a false positive.

• 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
• MDR Report Key: 8312458
• MDR Text Key: 137559276
• Report Number: 2245578-2019-00022
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 10054749001009
• UDI-Public: 10054749001009
• Combination Product (y/n): N
• PMA/PMN Number: K133002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2019
• Device Catalogue Number: 05P58-25
• Device Lot Number: F18325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR