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

Catalog Number	03P85-50
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a suspected discrepant results on a (b)(6) year old male patient with altered conditions.There was no additional patient information at the time of this report.The customer states that return product is not available for investigation.Date: method: sample: time: ph: pco2: po2: hco3: be: sat: tco2: lac: (b)(6)2017, i-stat, a, 01:44, 6.99, 41.9, 71, 10.1, -21, 80%, 11, 0.85.(b)(6)2017, i-stat, b, 02:03, 7.38, 41.3, 82, 24.5, -1.0, 96%, 26, 0.81.There are no injuries associated with this event.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 07/07/2017.Retain product was tested and functioning according to specification.Return product was not available for investigation.
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: 6665793
• Report Number: 2245578-2017-00029
• Device Sequence Number: 816644
• Product Code: CHL
• UDI-Device Identifier: 10054749002266
• UDI-Public: (01)10054749002266
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• 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): 07/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 03P85-50
• Device Lot Number: D17030A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 85