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

Catalog Number 11730347216

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

The customer questioned inorganic phosphorus (phos) results for an unknown number of patient samples.The customer is questioning phos results between reagent lot 60023601 and reagent lot 61065701.The samples were run at the customer site using both lot numbers and also at 2 different sites with lot 61065701.Of the data provided for 49 patient samples, 21 were erroneous.The erroneous results were reported outside of the laboratory.The initial phos tests were run at the customer site on (b)(6) 2015 with reagent lot 60023601.These results were reported outside of the laboratory.The physician called and indicated that the results were not what he expected to see.The samples were repeated on (b)(6) 2015 at the customer site and 2 other sites using reagent lot 61065701.The repeat results using the 2nd reagent lot were consistent with what the physician expected to see.No adverse event occurred.The analytical p module serial number was (b)(4).Water system maintenance was performed on (b)(6) 2015.The field service engineer checked multiple parts of the instrument and could not locate any issues.The vacuum pump was replaced.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Calibration and quality controls were acceptable.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The most likely root cause is related to pre-analytics or an issue specific to each sample (e.G.Drug interference).

Manufacturer Narrative

It was noted that during a service visit, contaminated probes were identified due to insufficient flushing inside the nozzle.After replacing the valves, replacing the tubing and removing the washes probe, no additional phos discrepancies occurred.

• Brand Name: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• Type of Device: PHOSPHORUS (INORGANIC) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4752903
• MDR Text Key: 5827616
• Report Number: 1823260-2015-03416
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K883962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 11730347216
• Device Lot Number: 60023601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/10/2015
• 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