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

Catalog Number 03183793122

Device Problem Low Test Results (2458)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

The alarm trace revealed abnormal aspiration alarms, low degasser pressure and insufficient detergent alarms around the time of the event.Calibration and qc data using the old reagent pack were reviewed.Calibration data on 12-sept-2021 revealed that signal one was about two times higher than previous signals.Qc data on 13-sept-2021 was noted to be very low.The consumable or reagent pack was noted to have caused the issue, as evidenced by the improvement of calibration, qc and patient results when it was replaced by the user.The user performed correlation tests with acceptable results.The field service engineer further inspected the rinse level and gear pump pressure.He ran precision tests for phosphate according to precision guidelines, which revealed acceptable results.Qc was performed by the user and was noted to be within normal ranges.After service, no further issues were reported by the customer.The investigation determined the customer's actions (replacing the reagent) along with the service actions resolved the issue.

Event Description

The initial reporter received questionable results for phos2 phosphate (inorganic) ver.2 tested on a cobas 6000 c (501) module.From (b)(6) 2021, 38 patient samples with low phosphate results were reported outside the laboratory.On (b)(6) 2021, the qc was noted to be very low.The reporter replaced the reagent pack with the same lot number in the analyzer, recalibrated and reran the qc.She then reran the same patient samples on the analyzer for correction.The reporter was able to provide an example of discrepant results for one patient sample.On (b)(6) 2021, the initial result was 0.7 mg/dl (the exact date of sample processing was not clearly stated, but (b)(6) 2021 was used as this was the date the specimen was collected).On (b)(6) 2021, the repeat result was 3.0 mg/dl.The repeat result was deemed to be correct.The c501 module serial number was (b)(4).

• 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
• 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: 12631537
• MDR Text Key: 276395003
• Report Number: 1823260-2021-02982
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (y/n): N
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 03183793122
• Device Lot Number: 54801701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• 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