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

Catalog Number 05171377190

Device Problems No Device Output (1435); High Test Results (2457)

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

Event Date 05/23/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation is ongoing.

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
• 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: 16241679
• MDR Text Key: 308126168
• Report Number: 1823260-2023-00232
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/17/2023
• 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
• Treatment: CO-DIOVAN; LIXIANA; OLFREX; SELECTRA; TENSINOR
• Patient Age: 83 YR
• Patient Sex: Female