MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROBNP II IMMUNOASSAY; TEST,NATRIURETIC PEPTIDE

Model Number PROBNP G2

Device Problems Failure to Calibrate (2440); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer ran calibration and qc on both reagent packs.Qc results were outside of the specified ranges and calibration failed for the reagent pack in question (sequence number (b)(4)).Calibration and qc were acceptable for the new reagent pack (sequence number (b)(4)).The investigation is ongoing.

Event Description

The initial reporter complained of discrepant results using a specific reagent pack for 1 patient sample tested for elecsys probnp ii (probnp ii) on a cobas 8000 system.The initial result was 6434 pg/ml.This result was reported outside of the laboratory where it was questioned by the physician.The customer replaced the reagent pack and the repeat result was 58.77 pg/ml.The 8000 system serial number was (b)(4).

Manufacturer Narrative

The customer returned the reagent pack for investigation.Sections d9 and h3 were updated.The containers were checked and there were no broken or leaky lids.The reagent fluid from the two bottles was colorless and transparent, however, there were slight particles observed in one bottle.These particles may have contributed to the issue, however, the root cause for these particles could not be determined.The investigation ran calibration and qc on the returned reagent pack on a cobas 6000 e 601 module and calibration failed.The customer's issue (failed calibration) was reproduced at the investigation site.The cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II IMMUNOASSAY
• Type of Device: TEST,NATRIURETIC PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10777216
• MDR Text Key: 214387551
• Report Number: 1823260-2020-02737
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• PMA/PMN Number: K072437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PROBNP G2
• Device Catalogue Number: 04842464190
• Device Lot Number: 435969
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 10/10/2020; 10/10/2020
• Supplement Dates FDA Received: 01/06/2021; 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1