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 admitted to the picu for infantile spasms.There was no patient information at the time of this report.The customer states that return product is available for investigation.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: 1003, method: i-stat, result: 8.0.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: 6752561
• Report Number: 2245578-2017-00078
• Device Sequence Number: 856336
• 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: 10 MO