MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ALNTY C CREATININE 3000

Catalog Number	07P99-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 07p99, which has a similar product distributed in the us, list number 03l81.
Event or Problem Description
The customer reports that one patient sample (sid (b)(6)) generated an initial alinity creatinine assay result of 3.37 mg/dl on an alinity c processing module.The sample retested at 0.69 mg/dl.No suspect results were reported from the lab.There is no impact to patient management reported.
Additional Manufacturer Narrative
The suspect medical device in the initial mdr was incorrect.Mdr number 3002809144-2018-00006 has been submitted with the correct suspect medical device and all further information will be documented under this mdr number.Change in suspect medical device of customer issue.

• Brand Name: ALNTY C CREATININE 3000
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7146078
• Report Number: 1628664-2017-00534
• Device Sequence Number: 19115800
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Catalogue Number: 07P99-20
• Device Lot Number: 12798UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1