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

Catalog Number	03P85-25
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	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Other product: list, description, lot#, pma/510k 03p88-25 cg8+ unk (b)(4).K940918, apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat cg4+ & cg8+ cartridges (lot# unk) that yielded a suspected discrepant hemoglobin result of 7.7 g/dl on a patient.There was no patient information available at the time of this report.Method date time hgb hct, sysmex (b)(6) 2021 05:45 7.7 g/dl ni, i-stat (b)(6) 2021 06:00 15.6 g/dl ni.Customer presented two cartridge products but only one i-stat result.It is unknown which cartridge product is associated with the lot.There were multiple attempts for information but to no avail.The customer stated they suspect an issue with the pre analysis of the sample (pb of homogenization).However, not confirmed at the time of the report.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 the limited 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).The investigation was completed on 25-jan-2022.The customer reported obtaining a discrepancy in hgb patient sample results between testing with i-stat cg4+ and cg8+ (cartridge lot numbers unknown) and a sysmex lab instrument.Hgb is calculated from the measured hct response per artwork 765792-00 rev.B, rev.Date: (b)(6) 2020, istat cg8+ cartridge.As hgb would only generate an erroneous result if the measured hct response it is dependent on was incorrect, hct was the focus of this investigation.A review of hct performance verification data of i-stat versus multiple reference instruments at multiple sites for clew a41 and a42 demonstrates that the overall performance of the i-stat hct is in agreement with other manufacturers.No deficiency has been determined.

• 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
• 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: 13170131
• Report Number: 2245578-2022-00004
• Device Sequence Number: 11880606
• Product Code: KHP
• UDI-Device Identifier: 10054749000132
• UDI-Public: 10054749000132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982071
• 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): 02/01/2022

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 Catalogue Number: 03P85-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 56 YR
• Patient Sex: Male