MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 10 MD; URINE TEST STRIPS

Catalog Number 03260763160

Device Problems No Device Output (1435); Non Reproducible Results (4029)

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

Event Date 10/01/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable blood, ketones, and protein results for an unspecified number of patient samples tested on a urisys 1100 analyzer with serial number (b)(4).The results were compared to accutest test strips and a precision urine analyzer.The initial results were reported outside of the laboratory.The reporter stated that they would run the visual test using accustrip test strips and the results would be negative.At the same time, the sample would be run on the analyzer and the blood, ketones, and protein results would be "abnormal." the reporter could not determine if they all occurred simultaneously, but these parameters would show "abnormal" on the urine analyzer.The reporter could not quantify the "abnormal" results received.The reporter stated that the urine would be cultured and 2-3 days later and they would come up negative.The reporter stated the results would also be negative on a non-roche analyzer (precision urine analyzer).The negative results from the visual read on the accustrips, the non-roche analyzer and the urine culture were deemed correct.The chemstrip 10 lot number is 64616808 with an expiration date of 30-nov-2023.

Manufacturer Narrative

It was confirmed that the customer does not run external qc on the meter.The urine analyzer and the test strips were requested for investigation.

Manufacturer Narrative

The retention material of lot 64616800 was measured on a urisys 1100 analyzer used for investigation.The results of all measurements fulfilled the requirements and no false positive results were observed.The customer's urisys 1100 analyzers with serial numbers (b)(6) were submitted for investigation.The analyzers were inspected and both analyzers showed no abnormalities.The investigation and the customer's urisys 1100 analyzers fulfilled the requirements.The retention materials were within specifications.Both the test strips and instrument passed qc checks and were released without restrictions.The investigation determined that the event was consistent with incorrect handling.The reported customer results showed a high scattering likely caused by the wrong positioning of the test strip in the tray.Product labeling states "place the test strip, with the test pads facing upward, on the tray so that its leading edge is held by the clip at the end of the test strip tray.The retaining bar must be open (see figure 10).About 2 mm of strip must be held under the clip.It is important that the strip is correctly positioned and ready to be read within 5-10 seconds of dipping strip.".

• Brand Name: CHEMSTRIP 10 MD
• Type of Device: URINE TEST STRIPS
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16036378
• MDR Text Key: 308348249
• Report Number: 1823260-2022-04164
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032437
• 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: 03/20/2023

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: 11/30/2023
• Device Catalogue Number: 03260763160
• Device Lot Number: 64616808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/20/2023
• 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