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U.S. Department of Health and Human Services

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

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ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE Back to Search Results
Catalog Number 600-9001-25
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2021
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 (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ionized calcium result of 1.56 mg/dl on a patient.There was no additional patient information.Method: i-stat , date: (b)(6) 2021 , k results: 1.56 mg/dl ; method: lab , date: (b)(6) 2021 , k results: 0.72 mg/dl.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.
 
Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 22-dec-2021.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing for the lot met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1- product complaint level 2 and level 3 investigation procedure for suppressed results and for points outside total allowable error (ea) for all sensors except ica.This related deficiency is being investigated in quality record (b)(4).
 
Event Description
Na.
 
Manufacturer Narrative
Apoc incident: # (b)(4).A memo regarding the investigation was completed on 13-may-2022.The memo determined that lot w21139a which was previously identified as a deficiency for ica points outside total allowable error was inadvertently bracketed with qr 775835.As a result qr 823211 was initiated to bracket lot w21139a.This follow up does not change the outcome of the investigation and solely for bracketing purpose.
 
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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
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 Key13059604
MDR Text Key290066811
Report Number2245578-2021-00109
Device Sequence Number1
Product Code CHL
UDI-Device Identifier10054749000163
UDI-Public10054749000163
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K940918
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/27/2022
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
Device Operator Health Professional
Device Expiration Date01/16/2022
Device Catalogue Number600-9001-25
Device Lot NumberW21139A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received12/22/2021
05/13/2022
Supplement Dates FDA Received01/05/2022
06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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