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

Catalog Number 03P84-25

Device Problem False Positive Result (1227)

Patient Problem Cancer (3262)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 06/14/2017, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant crea result of 2.5 mg/dl on a (b)(6) year old female with symptoms of lung and colon cancer.The customer states that on (b)(6) 2017 the same patient had a high crea of 3.0 mg/dl.The patient ws treated on results at the doctors office.There was no additional patient information at the time of this report.The customer states that return product is available for investigation.Date: (b)(6) 2017, (b)(6) 2017 , (b)(6) 2017; collect/test: 1101/1101, 1446/1446, 1450/unk; method: i-stat, i-stat, dr.Office; results: 2.5 mg/dl, 1.2 mg/dl, 0.7 mg/dl.Apoc suspects that the patient may have been taking hydroxyurea however, not confirmed at the time of this report.Per i-stat system manual art: (b)(4).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

Apoc incident # (b)(4).On (b)(6) 2017 the customer reported unexpected high creatinine results when comparing the i-stat analyzer to a lab analyzer at the doctor's office.On (b)(6) 2017 the incident was raised to a level 2, for investigation.On (b)(6) 2017 the customer new information was received stating that the patient was taking hydroxyurea during the time of the event.As per artwork 714183-00y rev date 07/15/2016, creatinine/crea, hydroxyurea is a known interferent where the i-stat creatinine results will be increased.Recommendation is to use another method.

Event Description

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• 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: 6698614
• MDR Text Key: 80057579
• Report Number: 2245578-2017-00033
• 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: 07/21/2017

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: 10/14/2017
• Device Catalogue Number: 03P84-25
• Device Lot Number: A17117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2017
• 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: 76 YR