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

Catalog Number 05171377190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with phos2 (phosphorus) on a cobas 8000 c702 module.The sample initially resulted in a phosphorus value of 0.9 mg/dl.Due to the value being low, the sample was repeated, resulting in a value of 9.5 mg/dl.The sample was repeated several times, but not additional values were provided.The 0.9 mg/dl value was deemed correct.

Manufacturer Narrative

The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Calibration and controls were acceptable.The customer indicated they did not receive any alarms.The field service engineer could not determine a cause.No issues were observed with reaction cell washing, probe washing, or probe adjustments.No issues were observed with calibration or controls.The investigation could not identify a product problem.The cause of the event could not be determined.The customer has not reported any additional issues.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18847427
• MDR Text Key: 337018676
• Report Number: 1823260-2024-00670
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• Combination Product (y/n): Y
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05171377190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 66 KG