MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER

Catalog Number	04P75-01R
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat analyzer sn (b)(4) that yielded suspected discrepant glucose results on multiple patients.There was no patient information available at the time of this report.Customer reports they ran cartridge lots h17265b and h17234 on a different analyzer and there have been no issues.I-stat(313271): glucometer: chemistry analyzer: result: 71, 42, 50.Result: 50, 42, 41.Result: 79, 52, 34.Result: 61, 48, 51.Result: 76, 48, 54.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 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).The investigation was completed on 04/24/2018.Failure analysis did not reproduce the complaint.Analyzer s/n (b)(4) functioned according to specification during testing and produced results that were within the acceptable values.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.

• Brand Name: I-STAT1 ANALYZER
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7260911
• Report Number: 2245578-2018-00037
• Device Sequence Number: 16433648
• Product Code: CGA
• UDI-Device Identifier: 00054749003600
• UDI-Public: 00054749003600
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• 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
• Report Date (Section B): 05/02/2018

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 Catalogue Number: 04P75-01R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1