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

Catalog Number 05P58-25

Device Problem False Positive Result (1227)

Patient Problem Bronchitis (1752)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Apoc incident (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 05/10/2016.Retain and return product was tested and found to be functioning according to specification.Investigation: the customer reported observing an unexpected result while using b-hcg cartridge lot a15323 to test a patient sample.The device history record for this lot was reviewed.The lot passed finished goods release criteria.Forty retained cartridges from the lot were tested using whole blood.Testing met the acceptance criteria found in q04.01.003 rev.X, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.

Event Description

On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result on a female patient who was diagnosed with acute bronchitis.There was no additional patient information available at the time of this report.Time, date of i-stat test, i-stat result: 04/08/16, 12:54, 41.5 iu/l.Time, date of beckman dxi test, lab result: drawn: 12:54,, results: 13:59 <5.0 iu/l.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4)).

• 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; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6932300
• MDR Text Key: 90298798
• Report Number: 2245578-2017-00360
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749001009
• UDI-Public: (01)10054749001009
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 05P58-25
• Device Lot Number: A15323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• 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