MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	08056757190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable alkaline phosphatase acc.To ifcc gen.2 (alp) and lactate dehydrogenase (ldh) results for 1 patient sample on a cobas c 503 analytical unit.The initial alp result was 213 u/l.The repeated results were 148 u/l, 64.8 u/l, 64.6 u/l, and 170 u/l.The initial ldh result was 419 u/l and the repeated results were 277 u/l and 259 u/l.The leukocyte values in this sample were in the normal range.This medwatch will apply to the alkaline phosphatase acc.To ifcc gen.2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the lactate dehydrogenase assay.
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The ldh lot number is 817145.The expiration date was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer performed hardware and precision checks with acceptable results.The investigation determined the issue was consistent with a high leukocyte concentration in the samples leading to an accumulation of cells close to the plasma surface.Falsely high ldh and alp values can occur if blood cells or cell debris are not properly removed in the pre-analytical sampling process.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• Brand Name: ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2
• Common Device Name: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21433605
• Report Number: 1823260-2025-00517
• Device Sequence Number: 4337283
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033185
• 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): 03/11/2025

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 Catalogue Number: 08056757190
• Device Lot Number: 844442
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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
• Patient Sex: Unknown