MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon retrospective review, it was discovered that the initial report was submitted under manufacturer report number 1628664-2018-02098 as abbott manufacturing inc, (b)(4) was incorrect.The correct manufacturer name, city and state is abbott (b)(4) which is this report.A review of the reaction graph for the suspect result and found an elevated absorbance reading.No customer returns were available for evaluation.A search of the complaint database by product lot number found no other tickets similar to the current complaint issue.The trend review by the product list numbers found no adverse or non-statistical trends related to this issue.Review of product labeling revealed adequate labeling for the interpretation of assay results and troubleshooting this complaint issue.The alinity ci-series system operations manual provides multiple probable causes for elevated and erratic results.A product deficiency was not identified.
Event or Problem Description
The customer observed falsely elevated results while using alinity c creatinine reagents.The following data was provided for the same patient.No specific patient information was provided.Sid (b)(6) initial 2.67 mg/dl.Repeat (no sid provided) 0.75, 0.71 mg/dl.Repeat using a new sample.(sid (b)(6)) 0.73 mg/dl.No impact to patient management was reported.

• 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: 9639133
• Report Number: 3002809144-2020-00072
• Device Sequence Number: 14174128
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 01/28/2020

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: 12/19/2018
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 75413UN17
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1