MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CORP. LIPASE COLORIMETRIC ASSAY; LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Catalog Number	03029590322
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: france.
Event or Problem Description
The customer complained of a questionable lipc lipase colorimetric assay result for 1 patient sample tested using two different application versions on a cobas 6000 c 501 module.The lipc result from one application version was 117 iu/l.The lipc result from the other application version was 30 iu/l.The erroneous result was released outside of the laboratory.There was no allegation of an adverse event.The cobas c501 serial number (b)(6).The patient sample was sent in for further investigation.The investigation is currently ongoing.

• Brand Name: LIPASE COLORIMETRIC ASSAY
• Common Device Name: LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS CORP.; 9115 hague rd.; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague rd.; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7788168
• Report Number: 1823260-2018-02327
• Device Sequence Number: 3491624
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: Other
• Device Catalogue Number: 03029590322
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown