MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CREATININE

Catalog Number	07P99-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information, patient identifier: multiple = (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated creatinine results on two patients.The results provided were: on (b)(6) 2019 sid (b)(6) creat = 13.98mg/dl / on (b)(6) 2019 new draw (sid (b)(6)) in er = 0.69mg/dl; on a second analyzer serial number (b)(4).The (b)(6) 2019 sample = 12.66mg/dl; on (b)(6) 2019 sid (b)(6) = 8.6mg/dl / 0.96mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
A ticket search by lot 64125un18 found normal complaint activity and no trends were identified related to this issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity c creatinine, lot 64125un18.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9088432
• Report Number: 3002809144-2019-00566
• Device Sequence Number: 2425256
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2020
• Device Catalogue Number: 07P99-30
• Device Lot Number: 64125UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C PROCESSING MODULE, LN 03R67-01; ALINITY C PROCESSING MODULE, LN 03R67-01; SERIAL # (B)(4).; SERIAL # (B)(4).