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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of questionable nitrite and ketone results on the urisys 1100 urine analyzer.The false positive nitrite results are erroneous.The false positive results were reported outside of the laboratory.The customer stated that positive nitrite results (0.15 mg/dl) were received when testing "everyone" (patient or staff).The hospital laboratory shows these results as "completely" negative.The actual results were not provided.The customer received false positive nitrite results of 0.15 mg/dl when testing multiple patients and staff on multiple days.The customer had run qc on the vial of test strips on (b)(6) 2017 and the results were normal.The customer has not run qc since this issue started.No adverse event occurred.All patients are documented as being in stable condition.No treatment was based on the false positive results.The urisys 1100 analyzer serial number was (b)(4).The meter and test strips were requested for investigation.

Manufacturer Narrative

The retention material of strip lot 21650400 was measured on a urisys 1100 used at the investigation unit with native urine and a nitrite-dilution.The results of the measurements fulfill the requirements.No false positive results were observed.

Manufacturer Narrative

The customer returned the meter and test strips.The test strips show some discoloration on various test pads.Additionally, the cardboard disc is of the test strip vial is arched convexly.The customer's test strips cannot be tested due to the discoloration of the test pads.The customer's test strips show evidence of humidity.The desiccant has been affected by moisture as seen by the bent cardboard disc of the test strip vial.Either moisture got into the vial, the test strips were contaminated by moisture and then put back in the vial or the vial was left open too long and not closed correctly.The incorrect results were caused by mishandling of the test strips at the customer site.Product labeling states: "in order to avoid exposure to moisture, the vial must be closed immediately after removal of a strip, using the original stopper, which contains a drying agent.".

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7213395
• MDR Text Key: 98193976
• Report Number: 1823260-2018-00200
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 21650403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• 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