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

Model Number LIPC

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 319768557
• Report Number: 1823260-2023-02231
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1