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

Model Number	LIPC
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Erroneous non-reproducible results were generated by a cobas 6000 c (501) module.The event involved a total of 1 patient with the following: one erroneous result for the lipc lipase colorimetric assay.
Additional Manufacturer Narrative
The patient has pancreatic cancer and the sample may have a high protein concentration.Product labeling states "in very rare cases, gammopathy, in particular type igm (waldenström's macroglobulinemia), may cause unreliable results." and "for diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings".High dilutions can cause a matrix effect which can lead to false high or low results depending on the initial lipase result.The root cause of the issue is the different influence of m proteins on the lipase results from different analyzers using different applications.The issue is related to the patient sample.The investigation did not identify a product problem.

• Brand Name: LIPC LIPASE COLORIMETRIC
• Common Device Name: LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8544222
• Report Number: 1823260-2019-90107
• Device Sequence Number: 1731308
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: LIPC
• Device Lot Number: 381204
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1