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

Catalog Number 11895354160

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 286849826
• Report Number: 1823260-2021-03533
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537180037
• UDI-Public: 00075537180037
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/15/2022
• 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: BUMEX; ESTRADIOL PATCH; EUTHYROX; LOSARTAN; METOPROLOL; POTASSIUM CHLORIDE; TRAMADOL; WARFARIN
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 102 KG