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

Catalog Number 04842464160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys probnp ii immunoassay results for 7 patient samples on a cobas 6000 e601 module, serial number (b)(4).The initial results were obtained between (b)(6) 2020 and the results were repeated between (b)(6) 2020.The initial results were reported outside of the laboratory.The repeated results were believed to be correct.

Manufacturer Narrative

The investigation found the the issue to be caused by micro-particles under the cap of the reagent pack.The field service representative replaced the reagent pack, which appeared to solve the issue.Qc results were normal with a new reagent pack.The investigation determined the service actions resolved the issue.

Manufacturer Narrative

The investigation found that the customer was not handling the reagent packs per the reagent method sheet and the cobas 6000 operator's manual: per the probnp method sheet "store the elecsys reagent kit upright in order to ensure complete availability of the microparticles during automatic mixing prior to use." per the operator's manual "check that there are no microbeads deposited on the inside of the transparent reagent cap.If yes, discard the e pack.".

• 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: 10623444
• MDR Text Key: 209790909
• Report Number: 1823260-2020-02423
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

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: 10/31/2020
• Device Catalogue Number: 04842464160
• Device Lot Number: 41299905
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 09/08/2020
• Supplement Dates FDA Received: 10/29/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR