MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG6+ CARTRIDGE

Catalog Number	03P77-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4) (cartridge), (b)(4) (analyzer).Product#: 04p75-01.Serial# : (b)(4).Mfg date:2015-12.Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 11-jun-2021, abbott point of care was contacted by a customer regarding i-stat eg6+ cartridges that yielded a suspected descrepant hemoglobin result of 16.0 g/dl on a female patient with anemia.There was no additional patient information available at the time of this report.Method: i-stat.Date : (b)(6) 2021.Time: 11:19.Hgb: 16.0 g/dl.Method: lab.Date: ni.Time: ni.Hgb: lab.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.The customer has also opted to replace the i-stat analyzer sn (b)(4) used during the event.The analyzer was replaced at no charge and will investigated separately.
Additional Manufacturer Narrative
Apoc incident: # (b)(4) (analyzer product).The investigation was completed on 15-jul-2021.The customer reported that analyzer s/n (b)(6) produced unexpected hemoglobin (hb) results on a patient sample when testing with eg6+ cartridge lot l21098.Failure analysis did not reproduce the complaint.The analyzer functioned according to specification during failure analysis.A rocketware search spanning six months revealed one similar incident and no evidence of a trend.No deficiency has been identified.
Additional Manufacturer Narrative
Apoc incident: #(b)(4) (cartridge product) the investigation was completed on(b)(6) 2021.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for eg6+ cartridge lot l21098.
Event or Problem Description
Na.

• Brand Name: I-STAT EG6+ CARTRIDGE
• Common Device Name: EG6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 12045523
• Report Number: 2245578-2021-00054
• Device Sequence Number: 3821101
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: 10054749000057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/31/2021

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: 12/06/2021
• Device Catalogue Number: 03P77-25
• Device Lot Number: L21098
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 08/27/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/21/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1