MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS B-CROSSLAPS; COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE

Catalog Number	09005781190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys b-crosslaps assay on a cobas e 801 analytical unit.Initial result: >6 ng/ml (reference range 0.21-0.44 ng/ml).The initial result did not match the patient's clinical diagnosis, and the sample was manually diluted with a low-concentration serum and repeated.The repeat results were as follows: 1st repeat result: >6 ng/ml (tested with a dilution factor of 1:2).2nd repeat result: 1.94 ng/ml (tested with a dilution factor of 1:4).3rd repeat result: 0.872 ng/ml (tested with a dilution factor of 1:8).The customer suspected an interference.
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
According to the provided information, the patient's rheumatoid factor value was 1750 miu/ml; this is more than the threshold tested for the elecsys b-crosslaps assay.Interferences were tested up to the listed concentrations (rheumatoid factors:

• Brand Name: ELECSYS B-CROSSLAPS
• Common Device Name: COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE
• 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: 22309715
• Report Number: 1823260-2025-01920
• Device Sequence Number: 8081374
• Product Code: JMM
• UDI-Device Identifier: 07613336171561
• UDI-Public: 07613336171561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 08/01/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 09005781190
• Device Lot Number: 807764
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian