MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ¿-AMYLASE EPS VER.2; SACCHAROGENIC, AMYLASE

Catalog Number	05167027190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable amylase eps ver.2 assay results for a patient sample tested on a cobas 8000 core unit.The initial result was -1 u/l (accompanied by a data flag).The repeat result was 199 u/l with a 5-fold dilution.The sample was repeated neat and the result was 0 (accompanied by a data flag), and with a 1:5 dilution, the result was 198 u/l.No erroneous result was released outside of the laboratory.An interference is suspected in the sample.
Additional Manufacturer Narrative
Qc was acceptable.Pre-analytical handling analysis showed no abnormalities.The customer has confirmed that this issue is not related to the instrument, as the verification results for this sample were consistent on other instruments.A review of the reaction monitor analysis showed that the kinetics of the undiluted sample look like a clearing up of a turbidity in solution.Due to the multiple medications involved, the observed kinetics likely stem from a combination of unknown factors, making a definitive root cause extremely difficult to pinpoint.The investigation did not identify a product problem.

• Brand Name: ¿-AMYLASE EPS VER.2
• Common Device Name: SACCHAROGENIC, AMYLASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24660351
• Report Number: 1823260-2026-01024
• Device Sequence Number: 9289875
• Product Code: JFJ
• UDI-Device Identifier: 04015630924875
• UDI-Public: 04015630924875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/13/2026

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: 09/30/2026
• Device Catalogue Number: 05167027190
• Device Lot Number: 91012401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BEVACIZUMAB INJECTION; BUTORPHANOL TARTRATE INJECTION; HUMAN ALBUMIN; MEROPENEM FOR INJECTION; OXALIPLATIN FOR INJECTION; PROPOFOL INJECTABLE EMULSION; RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING F
• Patient Sex: Unknown