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

Catalog Number	09005781190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys -crosslaps/serum immunoassay results for multiple patient samples on a cobas e 801 analytical unit.The customer provided an example of discrepant results for 4 patient samples.On (b)(6) 2023, patient 1 had an initial -crosslaps result of 70.4 pg/ml.The repeat result was 521 pg/ml.On (b)(6) 2023, patient 2 had an initial -crosslaps result of 63.3 pg/ml.The repeat result was 529 pg/ml.On (b)(6) 2023, patient 3 had an initial -crosslaps result of 60.6 pg/ml.The repeat result was 548 pg/ml.On (b)(6) 2023, patient 4 had an initial -crosslaps result of 60.1 pg/ml.The repeat result was 624 pg/ml.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on (b)(6) 2023 with acceptable results.Qc data was acceptable.Multiple sample alarms were observed during a review of the customer's alarm trace data.The field service engineer (fse) visited the customer site on (b)(6) 2023 and checked multiple parts of the instrument.The fse adjusted the sample probe alignment.The fse noted milky growth in the syringes.The investigation is ongoing.H3 other text : na.
Additional Manufacturer Narrative
Bubbles and foam were observed in the patient samples.The customer has since implemented a new centrifugation step after defrosting patient samples.Foam on samples may lead to low results for this assay.The root cause of the event was found to be consistent with pre-analytical sample handling issues.No product problem was identified.

• Brand Name: ELECSYS ¿-CROSSLAPS/SERUM
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17129878
• Report Number: 1823260-2023-01962
• Device Sequence Number: 15284457
• Product Code: JMM
• UDI-Device Identifier: 07613336171561
• UDI-Public: 07613336171561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/09/2023

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: 12/31/2023
• Device Catalogue Number: 09005781190
• Device Lot Number: 64789101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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