MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number	03P88-25
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	08/27/2022
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 31-aug-"2021", abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ph results on a female patient.There was no patient information at the time of this report.(b)(6).At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.Customer obtained an acceptable ph result of 7.37 at 23:15 with the siemens.The i-stat yielded two results of 7.071 at 23:21 and 7.165 at 23:25 on the repeats.The customer states that due to the two falsely depressed i-stat ph results, a caesarean section was performed at 23:45.The patient was tested on the siemens two more times after the caesarean and yielded acceptable results.With limited information it is unknown if the caesarean section was warranted due to other unknown medical circumstances.Information has been requested but to no avail.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident:(b)(4).The investigation was completed on 21-nov-2022.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing did not meet the applicable acceptance criteria as outlined in appendix 1 of q04.01.003 rev.Ak, product complaint level 2 and level 3 investigation procedure, for po2 points outside total allowable error (ea) in i-stat tricontrols level 2 (l2tri).All other acceptance criteria were met.A deficiency has been identified as retained cartridge testing did not meet the acceptance criterion with respect to po2 results outside ea as per appendix 1 of q04.01.003 rev.Ak, product complaint level 2 and level 3 investigation procedure, when testing with cg8+ lot w22062a and l2tri lot 311145 on i-stat alinity analyzers.Although a deficiency with respect to po2 results outside ea limits has been determined, a nonconformance quality record (qr) will not be raised.This determination was made under incident (b)(4) where it was concluded that when testing with cg8+ lot w22062a on i-stat alinity analyzers using blood samples, acceptance criteria as per q04.01.003 was met.A similar deficiency (low po2 results outside ea correlated with low po2 ical, when testing with control fluids and i-stat alinity analyzers) was previously documented and investigated under (b)(4).The investigation identified that analyzer type was a contributing cause, with further investigation documented under (b)(4).(b)(4) determined that insufficient equilibration due to continuous calibrant fluid movement is the cause of this issue.Since the root cause has been identified and action(s) are pending implementation to resolve the issue, a new nonconformance qr was not raised.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Common Device Name: CG8+ 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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 15417564
• Report Number: 2245578-2022-00133
• Device Sequence Number: 15107897
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K940918
• 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): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 03P88-25
• Device Lot Number: W22062A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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 Sex: Female