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

Catalog Number 03029590322

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable lipc lipase colorimetric assay results for one patient sample.The customer used cobas 6000 c (501) module serial number (b)(4).The initial result was 578 ui/l with a data flag.The repeat result with an automatic dilution was 827 ui/l.With a manual 1:20 dilution, the result was 896 ui/l.The result of 827 ui/l was reported to the doctor who decided to send the patient to the hospital.There another sample was drawn and the lipase result on another cobas 6000 c (501) module was 63 ui/l.The hospital called the laboratory who repeated the first sample and the result was 854 ui/l.On (b)(6) 2017, the first sample was sent to the hospital with results of 565 ui/l with a data flag, 974 ui/l with a data flag, and 963 ui/l.There was no allegation of an adverse event.It was suspected there was contamination or a mis-identification of the first sample.Other assays were unaffected.

Manufacturer Narrative

Additional information was received for the complaint.The customer believes the high results to be correct.The customer did not believe that the suspect sample was mislabeled because all other parameters were reproducible.Contamination of the patient sample is not likely as the high results were confirmed several times.The second sample was drawn less than 24 hours after the first sample.Pancreatitis was excluded for the patient because other enzymes remained normal.No medication was given to the patient.As calibration and qc data was acceptable, a general reagent issue was not suspected.Interference in the sample was unlikely as the second sample from the patient had a result in the normal range.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• Brand Name: LIPASE COLORIMETRIC ASSAY
• 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: 6581117
• MDR Text Key: 75612549
• Report Number: 1823260-2017-01058
• Device Sequence Number: 1
• Product Code: CHI
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2017

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: 12/31/2017
• Device Catalogue Number: 03029590322
• Device Lot Number: 205954
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided; 05/02/2017
• Supplement Dates FDA Received: 06/13/2017; 08/18/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1