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

Catalog Number 03P84-25

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant results on a (b)(6) female patient with parkinson's disease.Physician questioned the results as one month ago the patient was normal, so patient was sent to the hospital where the result was normal.The actual result was not available.There was no additional patient information at the time of this report.The customer states that return product is available for investigation.The customer states that the patient did have a prescription filled for hydroxyurea on (b)(6) 2017.However, it is unknown if the patient was on hydroxyurea that the time of the event.The patient was treated on based on hospital results date: (b)(6) 2017, method: i-stat, test time: unk, sample: a, result: 4.0; (b)(6) 2017, i-stat, unk, unk, 3.8.Per i-stat system manual art: 714183-00y.Hydroxyurea is a substance that is known to interfere with the i-stat creatinine assay resulting in increased i-stat creatinine results.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exits.The investigation is underway.

Manufacturer Narrative

(b)(4).

Event Description

Na.

• Brand Name: I-STAT CREA CARTRIDGE
• Type of Device: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6665795
• MDR Text Key: 78453786
• Report Number: 2245578-2017-00028
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: (01)10054749000125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Catalogue Number: 03P84-25
• Device Lot Number: A17051A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR