MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMYL2; LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Catalog Number	03183742122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with amylase (amyl2) on a cobas 8000 c 502 module (serial number unknown) and a cobas 6000 c (501) module (serial number (b)(4)).The results did not agree with the clinical status of the patient.The sample initially resulted in an amylase value of 460 u/l on the c 502 analyzer.Since the laboratory had no historical data from this patient, the initial value was reported outside of the laboratory to the patient.The patient's doctor asked the laboratory to repeat the sample since the result did not match the patient's clinical status.According to the patient's doctor, the patient had no pathologies.The complained sample was then repeated on the c 501 analyzer (b)(6) 2022.Resulting in an amylase value of 468 u/l.A second sample was also collected from the patient and tested (b)(6) 2022.Resulting in an amylase value of 53 u/l.
Additional Manufacturer Narrative
The second sample collected from the patient resulted in the following relevant test results: alb = 44.4 g/dl, ua = 3.2 mg/dl, bild = 0.1 mg/dl, bilt3 = 0.3 mg/dl, ca = 9.3 mg/dl, cho = 202 mg/dl, crej = 0.88 mg/dl, crp = 0.11 mg/dl, iron = 98 ug/dl, ggt = 18 u/l, gluc = 79 (no units provided), lip = 40 u/l, alt = 12 u/l, trigl = 128 mg/dl, tp = 6.6 g/dl, alp = 141 (no units provided), hdl = 81.2 mg/dl.
Additional Manufacturer Narrative
The customer has confirmed that the second sample was collected on (b)(6) 2022.
Additional Manufacturer Narrative
Quality control data was acceptable.The first three calibrations performed with the used reagent lot failed, but the fourth calibration performed was valid.A general reagent or hardware issue could be excluded.The maximum daily dose of the ancoron and lamotrigine medications the patient was taking could cause interference with the amylase assay.None of these drugs are suitable for acute therapy and must be taken long-term.When taken as tablets, a sharply rising plasma level in the short term is not to be expected.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: AMYL2
• Common Device Name: LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
• 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: 14137519
• Report Number: 1823260-2022-01091
• Device Sequence Number: 6254133
• Product Code: CDT
• UDI-Device Identifier: 04015630918935
• UDI-Public: 04015630918935
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/03/2022

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: 09/30/2022
• Device Catalogue Number: 03183742122
• Device Lot Number: 57734201
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 06/10/2022; 07/08/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/23/2022; 06/30/2022; 08/03/2022
• 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: ANCORON; ATORVASTATINA; CONCOR; ELIQUIS; LAMOTRIGINA
• Patient Sex: Female