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	09/03/2022
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.I-stat product information: product# 04p75-35, serial # (b)(4).26-sep-2011.Apoc incident # (b)(4).
Event or Problem Description
On 06-sep-2022, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges and i-stat sn (b)(4) that yielded a suspected discrepant result of 2.5 on a patient.There was no patient information available at the time of this report.Return product is available for investigation.Analyzer sn (b)(4) is being replaced at no charge and will be investigated separately.(b)(6).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 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).Analyzer investigation (896411): the investigation was completed on 16-nov-2022.The customer reported that analyzer s/n (b)(6) was giving discrepant patient results for potassium (k) and creatinine (crea) while running i-stat chem8+ cartridges from lots h22138 and h22164 with i-stat control level 1 (lot 101144), 3 (lot 121145), and calibration verification set (lot 21258).Additionally, the analyzer produced high chloride (ci) and low urea nitrogen (bun) results.Failure analysis could not be performed as analyzer s/n (b)(6) has not been returned to flex.A rocketware search spanning three months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 28-sep-2022.A review of the device history record confirmed the cartridge 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.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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 15382987
• Report Number: 2245578-2022-00130
• Device Sequence Number: 17500156
• Product Code: JGS
• UDI-Device Identifier: 10054749005519
• UDI-Public: 10054749005519
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183688
• 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,Followup
• Report Date (Section B): 11/18/2022

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 Expiration Date: 11/14/2022
• Device Catalogue Number: 09P31-26
• Device Lot Number: H22138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 11/16/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/01/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: 83 YR
• Patient Sex: Female