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

Catalog Number	04P75-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 12/21/2016.Product was tested and functioning according to specification.Investigation: for one patient, cl and tco2 results were higher than a second analyzer, and for another patient, cl displayed a star-out and the tco2 results were higher than a second analyzer.The customer complaint was reproduced.Analyzer s/n (b)(4) displayed star-outs for cl on one run, and bun and ica results were out of range (high) once each on separate cartridge runs.Additional cartridge runs were performed, and all results were within acceptance ranges.There were observations of residue, contamination, and possible wear and tear on the analyzer's internal components; however, there is no evidence to support that any of these observations caused or contributed to the complaint.A rocketware search spanning twelve months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat1 analyzer is meeting specification.
Event or Problem Description
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat1 analyzer sn (b)(4) that had lower results on na, k, cl, tco2, ica, bun, and hct when compared to second i-stat1 and/or vista on two patients.There was no patient information at the time of this report.Return product is available for investigation.(b)(6).At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4).

• 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: 6938653
• Report Number: 2245578-2017-00542
• Device Sequence Number: 11114927
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 10/10/2017

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: 04P75-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1