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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS PROBNP II; NATRIURETIC PEPTIDE TEST Back to Search Results
Catalog Number 09315268160
Device Problems Low Test Results (2458); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).The investigation is ongoing.
 
Event Description
There was an allegation of analyzer alarms and questionable probnp g2 elecsys result from the cobas 6000 e601 module.One example was provided of an initial result of 36 pg/ml with a data flag.The repeat result from another cobas e601 analyzer was 973.7 pg/ml.The questionable result was not reported outside the laboratory.The repeat result was believed correct as the patient's previous probnp result was 894 pg/ml.
 
Manufacturer Narrative
The field service engineer found an issue with the sample probe.He replaced the sample probe and adjusted the liquid level detection (lld) voltage.The customer performed qc.The investigation determined the service actions resolved the issue.
 
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Brand Name
ELECSYS PROBNP II
Type of Device
NATRIURETIC PEPTIDE TEST
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
ibaraki 312-8 504
JA   312-8504
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250-0457
MDR Report Key18685320
MDR Text Key335125985
Report Number1823260-2024-00394
Device Sequence Number1
Product Code NBC
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2024
2 Devices were Involved in the Event: 1   2  
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 Catalogue Number09315268160
Device Lot Number00722426
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received02/15/2024
Supplement Dates FDA Received02/16/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALBUTEROL; ASPIRIN; ENOXAPARIN; FERROUS SULFATE; FUROSEMIDE; INSULIN; LIDOCAINE PATCH; MUCINEX; NEBIVOLOL; OXYCODONE; TRAZODONE
Patient Age78 YR
Patient SexMale
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