MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2018
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 clinical chemistry creatinine reagents.The following data was provided.The customer uses normal range 0.5 to 1.4 mg/dl.Sid (b)(6) initial 2.8 mg/dl, repeat 0.89, 0.92 mg/dl.A precision study using the patient specimen showed values from 0.86 to 0.90 mg/dl.Due to the first elevated value, the patient was transferred to another hospital under suspicion of renal failure.No treatment was reported for the patient.During testing at the other hospital, the patient creatinine value was normal, however no specific value or method were provided.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints associated with the creatinine assay (list number 3l81, lot number 93990un18) and a review for complaint trends for the list number was performed.The review did not identify any trends associated with this issue.Additionally, labeling was reviewed and adequately addresses the issue under review.No systemic issues or deficiency was identified for the creatinine assay.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8081557
• Report Number: 1628664-2018-02014
• Device Sequence Number: 1692203
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K981799
• 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): 02/13/2019

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: 09/01/2019
• Device Catalogue Number: 03L81-22
• Device Lot Number: 93990UN18
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-40 SN (B)(4) ; LN 02P24-40 SN (B)(4)