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

Catalog Number	03P79-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.The investigation was completed on 06/29/2017.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Aa (product complaint level 2 and level 3 investigation procedure).Return testing did not meet the suppressed results acceptance criteria outlined in appendix 1 of q04.01.003 rev.Aa (product complaint level 2 and level 3 investigation procedure) due to a high rate of k+ star-outs.A deficiency has been determined for ec8+ cartridge lot k16342.Er 392082 has been raised to address this issue.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded suspected discrepant results on a (b)(6) male patient presented in the ed on a diabetic emergency.The patient was treated and discharged.There was no patient information at the time of this report.Lab analyzer make and model # are unknown.The customer states that the was no harm to the patient, patient was treated on the lab analyzer result.Return product is available for investigation.Date: (b)(6) 2017, time: 1635, method: i-stat, result: 7.1; (b)(6) 2017 1705, lab, 2.8.There are no injuries associated with this event.The investigation is underway.

• 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: 6752562
• Report Number: 2245578-2017-00077
• Device Sequence Number: 1243531
• Product Code: CHL
• UDI-Device Identifier: 10054749002266
• UDI-Public: (01)10054749002266(17)170928(10)D17030A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/28/2017

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 Expiration Date: 06/28/2017
• Device Catalogue Number: 03P79-25
• Device Lot Number: K16342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR