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

Catalog Number 03183793122

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event 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).

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.".

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
• Type of Device: 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
• MDR Text Key: 309392162
• Report Number: 1823260-2023-00420
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03183793122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female