MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPC; LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Model Number	LIPC
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ldl_c ldl-cholesterol plus 2nd generation results for 1 patient on a cobas 6000 c 501 module.On (b)(6)2023, the initial ldl result was 714 u/l.The sample was diluted and repeated and the result was 750 u/l.The initial results were reported outside of the laboratory.On (b)(6)2023, another sample was collected from the patient.The sample was sent to another laboratory and the ldl result was 40 u/l.On (b)(6)2023, a third sample was collected from the patient.The sample was run on the customer's c501 analyzer and the result was 36 u/l.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The correct test is lipc lipase colorimetric assay, not ldl_c ldl-cholesterol plus 2nd generation as stated in section b5 of the initial report.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: LIPC
• Common Device Name: LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16548085
• Report Number: 1823260-2023-00814
• Device Sequence Number: 6043065
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 08/31/2023
• Device Model Number: LIPC
• Device Catalogue Number: 03029590322
• Device Lot Number: 66083001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown