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

Model Number LIPC

Device Problem Non Reproducible Results (4029)

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

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event 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.

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
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12519152
• MDR Text Key: 273992134
• Report Number: 1823260-2021-02789
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (y/n): N
• Reporter Country Code: CB
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/16/2021
• 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
• Treatment: 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