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 No Information (3190)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 04/08/2016.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 a15313 to test a patient sample.The device history record for this lot was reviewed.The lot passed finished goods release criteria.Forty retained and twenty-five returned 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 (b)(6) female patient.There was no additional patient information available at the time of this report.(b)(6).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: 6932289
• MDR Text Key: 90250381
• Report Number: 2245578-2017-00358
• 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
• Report Date: 10/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Catalogue Number: 05P58-25
• Device Lot Number: A15313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• 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
• Patient Age: 21 YR