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

Catalog Number 08836736190

Device Problems Improper or Incorrect Procedure or Method (2017); Non Reproducible Results (4029)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

Calibration and qc were acceptable.No sample quality issues were identified by the customer.The customer stated the reagent was a "replenished reagent" with the rest of "several exhausted reagents." the investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys probnp ii (probnp ii) on a cobas 8000 e 602 module.The initial result was 17.59 pg/ml with a data flag.Due to the data flag, the sample was repeated with a result of 12548 pg/ml.This result was reported outside of the laboratory where it was believed to be incorrect.On (b)(6) 2022 the sample was repeated with a result of 65 pg/ml.The e602 module serial number is (b)(4).

Manufacturer Narrative

The customer mixed excess reagent material from previous reagent packs with the current reagent pack.Product labeling states: "the reagents in the kit have been assembled into a ready-for-use unit that cannot be separated." the investigation determined the event was due to off-label use at the customer site as reagent material should not be mixed.

• Brand Name: ELECSYS PROBNP II STAT IMMUNOASSAY
• Type of Device: NATRIURETIC PEPTIDE TEST
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15212143
• MDR Text Key: 304842254
• Report Number: 1823260-2022-02400
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: 01/31/2023
• Device Catalogue Number: 08836736190
• Device Lot Number: 561868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 09/06/2022
• 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