MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE RBC ASSAY; FOLIC ACID

Catalog Number 05944295190

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Miscarriage (1962)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

(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 folrbc assay.Please refer to the following medwatch patient identifiers for the other mentioned products: (b)(6).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 folrbc reagent contains boric acid (0.1-1% w/w), which is documented as a hazardous substance.It was also noted the customer uses reagents from various other manufacturers.

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.

• Brand Name: ELECSYS FOLATE RBC ASSAY
• Type of Device: FOLIC ACID
• 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 Key: 7138694
• MDR Text Key: 95529347
• Report Number: 1823260-2017-03092
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103716
• Number of Events Reported: 1
• 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 Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05944295190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly