MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC8+ CARTRIDGE

Catalog Number	600-9007-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident #: (b)(4).Product#: 6000-0000, serial#: (b)(4), mfg date: 03/04/2010.Analyzer being requested for investigation.Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded suspected discrepant bun and potassium results on a patient.There was no patient information available at the time of this report.Method: i-stat, date: (b)(6) 2019, bun: 124 mg, potassium: 79 mmol/l, sample: a (suspect incorrect result.Possibly 7.9).I-stat, (b)(6) 2019, 18 mg, 4.4 mmol/l, b.Collect and test times not provided.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 the limited information available that suggests the product was not performing within the variability of the assay.There was no patient information.The customer states that the potassium result was 79 mmol/l.However, the result appears to be incorrect.Per i-stat system manual art: 714174-00p, the reportable range for potassium is 2.0 - 9.0 mm/l.The customer has requested the analyzer be replaced, as the errors have occurred with two lots of cartridges.The errors in question have not been confirmed and the product has not been replaced.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).The investigation was completed on 06/12/2019.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for ec8+ lot k18343.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 06/24/2019.The customer reported that analyzer s/n (b)(4) produced unexpected k and bun results with ec8+ cartridges from lot k18343 and unexpected pco2 results with ec8+ cartridges from lot h18235a.Failure analysis could not be performed as analyzer s/n (b)(4) (apoc incident (b)(4)) has not been returned.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 03/20/2020.The customer reported that analyzer s/n (b)(6) produced unexpected k and bun results with ec8+ cartridges from lot k18343 and unexpected pco2 results with ec8+ cartridges from lot h18235a.Failure analysis did not reproduce the complaint.Analyzer s/n (b)(6) functioned according to specification throughout testing and produced results that were within the acceptance ranges.A rocketware search spanning six months revealed two similar incidents (non-reproducible unexpected pco2 results) and no evidence of a trend.No deficiency has been identified.

• Brand Name: I-STAT EC8+ CARTRIDGE
• Common Device Name: EC8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8540828
• Report Number: 2245578-2019-00112
• Device Sequence Number: 19268471
• Product Code: CHL
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2020

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: 07/10/2019
• Device Catalogue Number: 600-9007-25
• Device Lot Number: K18343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 06/24/2019; 03/20/2020
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/20/2019; 07/18/2019; 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1