MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOS2; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number	03183793122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with phos2 phosphate (inorganic) ver.2 on a cobas 6000 c (501) module.The sample initially resulted in a phosphate value of 0.30 mg/dl accompanied by a data flag indicating a high absorbance value.The sample was automatically repeated with decreased sample volume, resulting in a value of 17.51 mg/dl with a data flag.The 17.51 mg/dl value was reported outside of the laboratory.The next day, the patient had a second sample collected and it resulted in an initial value of 0.30 mg/dl accompanied by a data flag indicating a high absorbance value.The sample was automatically repeated with decreased sample volume, resulting in a value of 17.84 mg/dl accompanied by a data flag indicating decreased sample volume.An aliquot of the first sample was sent to another laboratory where it was tested on an au8000 system, resulting in a value of 5.1 mg/dl.The value of 5.1 mg/dl was deemed correct.The serial number of the c 501 analyzer is (b)(4).
Additional Manufacturer Narrative
The patient was diagnosed with multiple myeloma.Per product labeling: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".
Additional Manufacturer Narrative
The customer is advised to refer to the method sheet for guidance on sample handling.The customer must always evaluate the clinical picture of the patient in conjunction with the sample results.The investigation could not identify a product problem.

• Brand Name: PHOS2
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• 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: 16350110
• Report Number: 1823260-2023-00420
• Device Sequence Number: 6260612
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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 Catalogue Number: 03183793122
• Device Lot Number: ASKU
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/03/2023
• 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 Age: 61 YR
• Patient Sex: Female