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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable lipc lipase colorimetric result for one patient sample with cobas 6000 c501 module serial number (b)(4).On (b)(6) 2021, the initial result was 12,116 u/l.On (b)(6) 2021, a second sample was tested with a result of 65 u/l.Both results were reported outside of the laboratory.The physician questioned the results as he thought the value decreased too fast after treatment.
Additional Manufacturer Narrative
Qc trace was noted to be within normal ranges.As the patient's result after treatment was considered to be correct, a potential interference is unlikely.No reaction kinetics, instrument alarm report, or other test results from the patient were available to allow for further analysis.A general reagent problem can be excluded.No product problem was found.

• Brand Name: LIPC LIPASE COLORIMETRIC
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12519152
• Report Number: 1823260-2021-02789
• Device Sequence Number: 5159284
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Initial Reporter Country: CB
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (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): 11/16/2021

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: 10/31/2021
• Device Model Number: LIPC
• Device Catalogue Number: 03029590322
• Device Lot Number: 51260801
• 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: 09/03/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATROPINE; D-5-N (P); DOLIPRANE; DYNASTAT; ESMERON (ROCURONIUM); FENTANYL; HUMULIN (INSULIN; INVANZ; L-R (P); METOCLOPRAMIDE; METRONIDAZOLE; MIDAZOLAM; MORPHINE; MOTILIUM; NAC LONG; NEOSTIGMINE; NICARDIPINE; ONDANSETRON; PANTOPRAZOLE; PARACETAMOL; PARIET; PRIMOVIST; PROPOFOL-LIPURO; SIMETICONE; SUXZMETHONIUM CHLORIDE; VITAMIN B COMPLEX; ZANIDIP
• Patient Sex: Unknown