MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number	07P9930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
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.Patient information: no further information is available.
Event or Problem Description
The customer obtained a falsely elevated alinity c creatinine result for a male cancer patient.Sample id (b)(6) generated 4.28 mg/dl and repeat the next day under sid (b)(6) generated 1.11 mg/dl.The customer further indicated the subsequent sample from the patient also generated 1.1 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
No customer returns were available for investigation.A search of complaints for lot: 04089un19, determined there were no similar reports for this issue.Review of trending reports for the alinity c creatinine assay found no trends related to this issue.The manufacturing documentation associated with the reagent lot were reviewed and did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information no systemic issue nor product deficiency was identified.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9757365
• Report Number: 3002809144-2020-00138
• Device Sequence Number: 11596220
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 05/13/2020
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 04089UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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; ALINITY C PROCESSING MODULE, LIST 03R67-01,; LIST 03R67-01, SN: (B)(6).; SERIAL: (B)(6).