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	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the lipc (lipase colorimetric assay) assay on a cobas 4000 c311 stand alone system (serial number (b)(6).The initial reporter also mentioned random quality control errors.The sample initially resulted in an lipc value of 83 u/l, accompanied by a data flag.The sample was repeated resulting in a value of 30 u/l.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer ran instrument performance testing which was out of specifications.A misadjusted gear pump and sample probe were found.After the gear pump, the sample probe position and the rinse arm flow were adjusted, instrument performance testing was repeated, and was within specifications.The investigation determined the service actions performed resolved the issue.

• 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: 17309419
• Report Number: 1823260-2023-02231
• Device Sequence Number: 6384418
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/29/2023

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: 09/30/2023
• Device Model Number: LIPC
• Device Catalogue Number: 03029590322
• Device Lot Number: 66460101
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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