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

Catalog Number 03183793122

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The customer found a defective reagent pack and that the probe tip was blocked with plastic.The probe was replaced.Precision studies were performed and were acceptable.The investigation is ongoing.

Event Description

The initial reporter complained of a questionable phos gen.2, result for 1 patient sample, on a cobas 6000 c (501) module analyzer serial number (b)(4).The initial result was 1.9 mg/dl and the repeat result was 3.4 mg/dl.The initial result was reported outside the laboratory.

Manufacturer Narrative

It was previously stated the customer found "that the probe tip was blocked with plastic.The probe was replaced.Precision studies were performed and were acceptable." this was corrected to having been found by the field service engineer.The last calibration was performed on (b)(6) 2020 with acceptable results.No further issues were reported after the service visit.The investigation determined that the issue found by the field service engineer was the root cause of the event.

• 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: 11438858
• MDR Text Key: 268488684
• Report Number: 1823260-2021-00697
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 03183793122
• Device Lot Number: 48358501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR