• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CK CREATINE KINASE LIQUID, ACC. TO IFCC CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS CK CREATINE KINASE LIQUID, ACC. TO IFCC CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM Back to Search Results
Catalog Number 04580591190
Device Problem Human Factors Issue (2948)
Patient Problem Miscarriage (1962)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
The customer has 3 modular pre-analytics systems and each is connected to 3 modular analytics p module analyzers, 3 modular analytics e170 analyzers, 1 cobas 6000 c (501) module,1 cobas integra 800 analyzer, and 3 cobas c513 analyzers. The serial numbers of the analyzers were not provided. Aside from safety information documented in the material safety data sheet for each product, the operator is instructed to follow safety precautions provided in the operator's manual labeling. The safety precautions include: -when handling reagents or other solutions, exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as goggles, gloves). - observe the cautions given in the package insert and observe the information given in the material safety data sheets available for roche diagnostics reagents and cleaning solutions. - be careful when removing open reagent packs from the instrument. They may contain residues of reagents. - avoid direct contact with cleancell m, sysclean, probewash m, or hitergent. - if a reagent, detergent or other working solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician. - observe the system safety labels illustrated in safety labels section of the system operator's manual. The customer did not provide any additional information in relation to the event. The cause of miscarriage remains unclear. With such limited information, no medical assessment was possible. The labeling of the reagents used by the customer followed international rules and indicated potentially toxic substances adequately.
 
Manufacturer Narrative
This event occurred in (b)(6). (b)(4).
 
Event Description
The customer stated that an employee at the site miscarried after exposure to some reagent. The customer was concerned about exposure to the following reagents: ck creatine kinase liquid, acc. To ifcc (ck), bilt3 bilirubin total gen. 3 (tbil), and the elecsys folate rbc assay (folrbc). These reagents were identified as having health hazard pictograms with hazard statements relating to risk of damage to fertility or the unborn child in product labeling (package insert). This medwatch will apply to the ck assay. Patient identifiers for the other mentioned products: (b)(4). No further patient details were provided and the date of the event was not provided. Additional details regarding the event and the patient have been requested in 2 follow-ups with the customer. Additional attempts to obtain more information will be made. Information regarding personal protective equipment use by the employee has been requested but not provided. Inhalation of the of the complained reagents is not likely due to high boiling points and low vapor pressure for the substances of concern. Transcutaneous absorption of the reagents could not be excluded, but skin contact should be prevented when safety instructions documented in product labeling are followed and personal protective equipment are worn by the user. The reagent 1 bottle of the ck reagent contains imidazole (8. 4 g/l), which is documented as a hazardous substance. It was also noted the customer uses reagents from various other manufacturers.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCK CREATINE KINASE LIQUID, ACC. TO IFCC
Type of DeviceCREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM
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
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key7138689
MDR Text Key108518461
Report Number1823260-2017-03090
Device Sequence Number1
Product Code CGS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K921661
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04580591190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
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
Type of Device Usage

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
-
-