MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.
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.Sid (b)(6) initial 2.67 mg/dl.Repeat (no sid provided) 0.75, 0.71 mg/dl.Repeat using a new sample ((b)(6)) 0.73 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Upon retrospective review, it was discovered that the manufacturer name, city and state (section d3) on the initial report listed as abbott manufacturing inc, 1921 hurd drive, irving, tx, 75038, usa was incorrect.The correct manufacturer name, city and state is abbott gmbh, max-planck-ring 2, wiesbaden, 65205, germany.All further information will be documented under mdr number 3002809144-2020-00072.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8126514
• Report Number: 1628664-2018-02098
• Device Sequence Number: 1653134
• 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,Followup,Followup
• 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
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 01/21/2020
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/21/2019; 01/28/2020
• 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 ANALYZER; ALINITY C ANALYZER; ALINITY C ANALYZER; LN 03R67-01 SN (B)(6); LN 03R67-01 SN (B)(6); LN 03R67-01 SN (B)(6)