MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ACT CELITE CARTRIDGE

Catalog Number	03P86-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident #: (b)(4).2nd lot used of the same product: lot#: r20025a, expiration date: 07/23/2020, mfg date: 01/25/2020.Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 07/15/2020, abbott point of care was contacted by a customer regarding act celite cartridges that yielded generated total of 11 star outs on one patient.There was no patient information available at the time of this report.Return product is not available for investigation.Customer states that the initial actc test at 9:17am with actc lot r20040 had a result of 133 secs and then patient was administered heparin dosage.The 13th and final actc test done at 12:34pm had a result of 500 secs using actc lot r20025a.All actc tests were done with fresh patient samples collected as whole blood arterial sample taken from reservoir port of by-pass pump and transferred by plain 3cc/18g syringe to cartridge.The customer stated that there were no issues reported with testing other patients using same actc lots r20025a and actc lot r20040.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Apoc has made six attempts to obtain information from the customer but to no avail.Although there is potential for a significant delay, a delay was not reported, nor impact to patient management.The customer stated that the issue is specific to this patient.Medication, sequence of events were requested specific to the patient but to no avail.The reporting decision was based on the limited 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 (b)(6)2020.A review of the device history records (dhrs) confirmed that the cartridge lots passed release specifications.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• Brand Name: I-STAT ACT CELITE CARTRIDGE
• Common Device Name: ACT CELITE CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton, nj
• MDR Report Key: 10358071
• Report Number: 2245578-2020-00085
• Device Sequence Number: 17010031
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023571
• 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): 08/18/2020

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: 08/07/2020
• Device Catalogue Number: 03P86-25
• Device Lot Number: R20040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1