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 Hyperglycemia (1905); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).

Event Description

On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result of 28.0 on a (b)(6) year old female patient.The sample was spun down and repeated on i-stat and the results was negative.The patient was presented in the emergency department for vomiting, sore throat, and bgl >600 and admitted.It is unknown at this time if return product is available for investigation.(b)(6).There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 03/09/2017.Retain product was tested and the customer complaint was not reproduced.Return product was not available for investigation.

• 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: 5959329
• MDR Text Key: 55336258
• Report Number: 2245578-2016-00097
• 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: 03/17/2017

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: 09/14/2016
• Device Catalogue Number: 05P58-25
• Device Lot Number: A16101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2016
• 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 Outcome(s): Hospitalization; Disability
• Patient Age: 26 YR