MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Model Number	3L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
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.
Event or Problem Description
The customer stated that a falsely elevated architect creatinine result of 6.7 mg/dl was generated for a patient sample (id (b)(6)) that retested at 1.455 mg/dl.The customer's reference range is 0.72 to 1.25 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.A review of instrument logs and quality control (qc) results was performed by a technical service specialist.No technical issues were identified.A review of the reaction graph for the sample in question was also performed.Irregular fluctuations were observed before and after the addition of r2.These factors suggest the likelihood of a interfering factor in the sample material such as fibrin.The sample retest which gave acceptable results was performed after re-centrifuging the sample which also indicates a potential sample interferent such as fibrin.Based on the available information, 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: 7341986
• Report Number: 1628664-2018-00113
• Device Sequence Number: 11094202
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: (01)00380740005979(17)190107(10)45325UN17
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K981799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 01/07/2019
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 45325UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1