MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOS2 PHOSPHATE (INORGANIC) VER.2; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number 03183793122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

The alarm trace showed multiple abnormal aspiration alarms.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with phos2 phosphate (inorganic) ver.2 on a two cobas 8000 c 502 module analyzers and an unknown roche cobas clinical chemistry analyzer.No incorrect results were reported outside of the laboratory.The first sample initially resulted with a phosphorus value of 7.65 mg/dl when tested on the first c 502 analyzer.The sample was repeated on an unknown competitor dry chemistry system, resulting with a value of 3.1 mg/dl on (b)(6) 2019.The sample was repeated on an unknown roche clinical chemistry analyzer, resulting with a value of 8.16 mg/dl on (b)(6) 2019.The sample was also repeated on a second c 502 analyzer, resulting with a value of 8.0 mg/dl on (b)(6) 2019.The second sample initially resulted with a phosphorus value of 4.63 mg/dl when tested on the first c 502 analyzer on (b)(6) 2019.The sample was repeated on an unknown competitor dry chemistry system, resulting with a value of 2.6 mg/dl.The sample was also repeated on a second c 502 analyzer, resulting with a value of 4.54 mg/dl on (b)(6) 2019.The serial number of the first c 502 analyzer was (b)(4).The serial numbers of the second c 502 analyzer and unknown roche clinical chemistry analyzer were requested, but not provided.

Manufacturer Narrative

The calibration data was acceptable.The qc data are within specifications.A reagent issue is not likely.The issue is consistent with a pre-analytic handling problem.The investigation did not identify a product problem.

• Brand Name: PHOS2 PHOSPHATE (INORGANIC) VER.2
• Type of Device: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9190259
• MDR Text Key: 217118742
• Report Number: 1823260-2019-03714
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• PMA/PMN Number: K983503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 03183793122
• Device Lot Number: 40875201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR