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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS AMYL2; LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES Back to Search Results
Catalog Number 03183742122
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Event 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.
 
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.
 
Manufacturer Narrative
The customer has confirmed that the second sample was collected on (b)(6) 2022.
 
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.
 
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Brand Name
AMYL2
Type of Device
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 Key14137519
MDR Text Key298899159
Report Number1823260-2022-01091
Device Sequence Number1
Product Code CDT
UDI-Device Identifier04015630918935
UDI-Public04015630918935
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972250
Number of Events Reported1
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,Followup,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Catalogue Number03183742122
Device Lot Number57734201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
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 Number1
Treatment
ANCORON; ATORVASTATINA; CONCOR; ELIQUIS; LAMOTRIGINA
Patient SexFemale
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