MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS BETA-CROSSLAPS/SERUM; HYDROXYPROLINE TEST SYSTEM

Catalog Number	07026960190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was not received for investigation.The investigation reviewed the calibration data.The calibrator 1 signal is within range and the calibrator 2 signal is slightly below the lower range.The investigation reviewed the qc data and the results were within specifications before the patient sample was run.The investigation reviewed the alarm trace and no issues were noted.The investigation reviewed the customer's handling of patient samples.The patient sample tube was centrifuged in a fixed-type centrifuge unit.The investigation determined that swing-out rotors be used for the centrifugation of the sample tube.The investigation reviewed the images from the sample-foam detection camera and no issues were noted.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 core unit is 2137-04.The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys b-crosslaps/serum (b-crosslaps) results from one patient sample tested on the cobas 8000 core unit.On (b)(6) 2024, the initial result from the analyzer was <10 pg/ml.The first repeat result was consistent.The reporter noted that the patient has osteoporosis and secondary hyperparathyroidism and that her other bone markers (n-mid and tp1np) were both within the reference range.The reporter questioned the initial result and sent the patient sample for further testing using a domestic platform with chemiluminescence immunoassay (clia) as the laboratory method.On (b)(6) 2024, the second repeat result from the domestic platform using the clia method was 34 pg/ml (reference range <1017 pg/ml).

• Brand Name: ELECSYS BETA-CROSSLAPS/SERUM
• Common Device Name: HYDROXYPROLINE TEST SYSTEM
• 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: 19312618
• Report Number: 1823260-2024-01443
• Device Sequence Number: 16896423
• Product Code: JMM
• UDI-Device Identifier: 04015630940141
• UDI-Public: 04015630940141
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K993706
• 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): 06/14/2024

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: 12/31/2024
• Device Catalogue Number: 07026960190
• Device Lot Number: 745601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/14/2024
• 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: ANTI-OSTEOPOROSIS DRUGS
• Patient Age: 69 YR
• Patient Sex: Female