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

Catalog Number	05171377190
Medical Device Problem Codes	No Device Output (1435); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable phosphorus gen.2 results for one patient from cobas 8000 c702 module serial number (b)(4).The customer alleged interference in the samples.On (b)(6) 2022, the result was 9.80 mg/dl.The sample was repeated and the same result was obtained.On (b)(6) 2022, the result from a new sample was 9.58 mg/dl.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited data, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16241679
• Report Number: 1823260-2023-00232
• Device Sequence Number: 12413714
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 12/31/2022
• Device Catalogue Number: 05171377190
• Device Lot Number: 57491001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CO-DIOVAN; LIXIANA; OLFREX; SELECTRA; TENSINOR
• Patient Age: 83 YR
• Patient Sex: Female