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)
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.
Event or Problem Description
The customer observed falsely elevated results while using clinical chemistry creatinine reagents.The customer uses reference range 0.57 to 1.11 mg/dl.Patient 1 (no sid provided) specimen 1 initial 5.9 mg/dl, repeat 0.70 mg/dl; specimen 2 initial 0.72 mg/dl patient 2 (sid (b)(6)) specimen 1 initial 7.82 mg/dl, repeat 0.55 mg/dl; specimen 2 0.55 mg/dl patient 3 (sid (b)(6)) initial 7.95 mg/dl, repeat 0.77 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
Further invesitgation of the customer issue included a review of complaint text, a search for similar complaints, and a review of labeling.A field service representative cleaned the bottom of the cuvette and replaced the lamp, which resolved the issue.A trend review of complaint activity did not identify any trends associated with this specific issue.Labeling was reviewed and was found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8224218
• Report Number: 1628664-2019-00010
• Device Sequence Number: 18898078
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/25/2019

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: 11/22/2019
• Device Catalogue Number: 03L81-22
• Device Lot Number: 86462UN18
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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; LIST 02P24-40, SERIAL (B)(4); LN 02P24-40 SN (B)(4)