MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number	03P85-50
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant results on a patient.There was no patient information at the time of this report.The customer states that return product is not available for investigation.Date/time collected , test time, ph, method, sample, sample type: (b)(6) 2017, 19:55pm, 20:03, 7.067 i-stat, a , wb/venous and (b)(6) 2017, 20:35pm, 21:3,5 7.32 abl800, b , wb/venous.There are no injuries associated with this event.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 11/03/2017.Retain product was tested and functioning according to specification.Return product was not available.
Event or Problem Description
Na.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Common Device Name: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6805222
• Report Number: 2245578-2017-00277
• Device Sequence Number: 19209570
• Product Code: KHP
• UDI-Device Identifier: 10054749002266
• UDI-Public: (01)10054749002266
• Combination Product (Y/N): N
• PMA/510(K) Number: K982071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2017
• Device Catalogue Number: 03P85-50
• Device Lot Number: D17086C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1