MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number	09P31-26
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-jan-2023, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges that yielded a suspected discrepant hematocrit result on a 67 year old male patient presented for shoulder surgery.There was no additional patient information available at the time of this report.Method date collected tested hb (g/dl) hct(g/dl) sample lab on (b)(6) 2022, 06:35 07:11 cancelled venous #1, i-stat on (b)(6) 2022, 07:35 07:35 15.3 45 venous #2, lab on (b)(6) 2022, 07:35 08:32 4.8 17.3 venous #2, lab on (b)(6) 2022, 10:43 11:23 4.4 16.1 venous #3, lab on (b)(6) 2022, 11:55 12:09 4.2 15.4 fingerstick #1.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident#: (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 15-feb-2023.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.Returned cartridge testing met the acceptance criteria for suppressed results but the size was too low (<17) to assess the rate of points outside total allowable error (ea).No deficiency has been identified.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ 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: 16183639
• Report Number: 2245578-2023-00008
• Device Sequence Number: 16727152
• Product Code: JGS
• UDI-Device Identifier: 10054749005519
• UDI-Public: 10054749005519
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 02/01/2023
• Device Catalogue Number: 09P31-26
• Device Lot Number: H22217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male