MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 UA; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11895354160

Device Problems Burst Container or Vessel (1074); Unsealed Device Packaging (1444)

Patient Problem Irritation (1941)

Event Date 01/07/2014

Event Type  Injury  

Manufacturer Narrative

The customer material was not available for investigation.Relevant retention material was visually checked.The retention vials were opened three times.For all checked vials, the stopper showed no abnormalities after opening.No further customer complaints have been received for the lot number.This was determined to be an isolated event.

Event Description

The customer reported an issue with the chemstrip 10 ua product.The user opened the lid of the chemstrip 10 ua vial as usual and all the dessicant spilled and burst out of the lid of the canister.One piece of dessicant got into the user's eye.The user stated that most of the dessicant hit her laboratory coat and avoided her skin.One small piece entered the user's right eye.The user immediately rinsed her eye with copious amounts of water.The piece was removed by the eye flushing and it came out without intervention.The eye was slightly irritated, but not red.The user went to the emergency room to have her eye checked.The physician put a stain in her eye to make sure the eye was not scratched by the dessicant particle.The physician determined that the eye was not scratched.Upon follow up with the user, the user indicated that the irritation to her eye had almost completely disappeared.The user was wearing a laboratory coat and gloves, but no eye protection.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

• Brand Name: CHEMSTRIP ® 10 UA
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3581304
• MDR Text Key: 15882735
• Report Number: 1823260-2014-00351
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 11895354160
• Device Lot Number: 22211001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/07/2014
• 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
• Treatment: PRENATAL VITAMINS
• Patient Outcome(s): Required Intervention
• Patient Age: 025 YR