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

Catalog Number	11895354160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strips were requested for investigation.The retention material of lot 51475500 was visually checked and qc documentation was checked.The retention material showed no abnormalities and fulfill the requirements.Qc documentation showed no abnormalities.
Event or Problem Description
The initial reporter received a questionable leukocytes result for one patient urine sample with a urisys 1100 urine analyzer serial number (b)(4).The leukocyte result from the meter was negative.The patient sample was sent for a laboratory culture that reported >100,000 e.Coli.No urinalysis dipstick test was performed at the laboratory.The questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
No product was returned for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 UA
• Common Device Name: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• 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: 12897543
• Report Number: 1823260-2021-03533
• Device Sequence Number: 17118595
• Product Code: JIL
• UDI-Device Identifier: 00075537180037
• UDI-Public: 00075537180037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K896454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 11895354160
• Device Lot Number: 51475511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUMEX; ESTRADIOL PATCH; EUTHYROX; LOSARTAN; METOPROLOL; POTASSIUM CHLORIDE; TRAMADOL; WARFARIN
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 102 KG