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

Catalog Number 03P88-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On 09-mar-2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant hematocrit result on an (b)(6) year old male patient post fall from ladder; complaint of pain to right side body.There was no additional patient information available at the time of this report.Return product is not available for investigation.Analyzer: lab.Date: (b)(6) 2021.Collected/tested: 11:40am/12:09pm, 41% pcv.Hematocrit : 13.3 g/l.Hemoglobin: 218 mg/dl.Glucose:.Analyzer: i-stat.Date: (b)(6)2021.Collected/tested: 11:59am/11:59pm, 17% pcv.Hematocrit : 5.8 g/dl.Hemoglobin: 158 mg/dl.Glucose:.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 patient was transfused 2 units prbcs (660mls) at 11:54 am.The customer stated that the patient was transfused based only upon the patient condition.The investigation is underway.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 08-jun-2021.The customer reported obtaining a discrepancy in glu, hct and hgb patient sample results between i-stat cg8+ cartridge lot w20351a and the lab instrument.A review of the device history record confirmed the cartridge lot met finished goods release criteria.A deficiency has been determined for cg8+ cartridge lot w20351a as retained testing did not meet the acceptance criteria found in (b)(4) rev.Af, appendix 1 - product complaint level 2 and level 3 investigation procedure for rate of ica results outside of total allowable error.This deficiency will be investigated under quality record (qr) (b)(4).

• Brand Name: I-STAT CG8+ CARTRIDGE
• Type of Device: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 11589658
• MDR Text Key: 260280004
• Report Number: 2245578-2021-00024
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Catalogue Number: 03P88-25
• Device Lot Number: W20351A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR