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

Catalog Number 03260763160

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's instrument and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant erythrocyte results for one patient tested on a urisys 1100 analyzer serial number (b)(4) compared to visual reading.The customer confirmed qc was acceptable and there was no test strip discoloration before patient testing.The customer used fresh urine for both tests.The patient's erythrocyte result on the urisys 1100 analyzer was negative.The patient's erythrocyte result by a visual reading was positive.

Manufacturer Narrative

The customer's test strips and analyzer were requested and returned for investigation.The customer's test strips, lot 42219903, had an expiration date of 30-nov-2020.The customer's test strips showed no abnormalities.The customer's analyzer and tray were clean and showed no damages.Due to the customer's test strips being expired once received for an investigation, the investigation used retention test strips for testing.The customer's urisys 1100 urine analyzer, an investigation's urisys 1100 analyzer, and an investigation's cobas u411/urisys 1800 were measured with randomly selected retention material lot 51950500 with of 0-native-urine and an erythrocytes-dilution-series.Neither the retention analyzers nor the customer's analyzer showed any false-negative results.Per product labeling, "false negative readings are obtained when formalin is used to preserve the urine or on medications with nitrofurantoin and quinidine." also, "nitrite in excess of 10 mg/dl in the urine (which is rare in urinary tract infections) delays the reaction" and "medications with 2-mercaptoethanesulphonatesodium (mesna) can lead to false positive or false negative reading of reagent pad color change." under the performance section, "a field study of 637 freshly voided urine specimens in routine diagnosis produced no false-negative results and in only a small percentage of cases, recorded a higher erythrocyte concentration than the ten-field sediment method." the investigation did not identify a product problem.The cause of the event could not be determined.Updated medwatch fields d9 and h3.

• Brand Name: CHEMSTRIP 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11056044
• MDR Text Key: 244805024
• Report Number: 1823260-2020-03325
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: 11/30/2020
• Device Catalogue Number: 03260763160
• Device Lot Number: 42219903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1