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 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable ldl_c ldl-cholesterol plus 2nd generation results for 1 patient on a cobas 6000 c 501 module.On (b)(6)2023, the initial ldl result was 714 u/l.The sample was diluted and repeated and the result was 750 u/l.The initial results were reported outside of the laboratory.On (b)(6)2023, another sample was collected from the patient.The sample was sent to another laboratory and the ldl result was 40 u/l.On (b)(6)2023, a third sample was collected from the patient.The sample was run on the customer's c501 analyzer and the result was 36 u/l.The analyzer serial number is (b)(4).

Manufacturer Narrative

The correct test is lipc lipase colorimetric assay, not ldl_c ldl-cholesterol plus 2nd generation as stated in section b5 of the initial report.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 16548085
• MDR Text Key: 311579321
• Report Number: 1823260-2023-00814
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/18/2023

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: 08/31/2023
• Device Model Number: LIPC
• Device Catalogue Number: 03029590322
• Device Lot Number: 66083001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/18/2023
• 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