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

Catalog Number 03260763160

Device Problem False Negative Result (1225)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

The initial reporter questioned results for erythrocytes from 2 urine samples from 1 patient run on 3 different urisys 1100 instruments using the same strip lot number.The urisys 1100 serial numbers are: (b)(4) (meter a), (b)(4) (meter b), and (b)(4) (meter c).The urine sample tested on meter a was a freshly voided sample obtained in the doctor¿s office on (b)(6)2023.The urine sample tested on meter b and meter c was a urine sample the patient brought in from home that was also voided on (b)(6)2023 into "whatever container the patient had available." at approximately 9:00 a.M.The sample obtained in the office was run on meter a with a negative result.The urine sample the patient brought from home was run on meter c with a negative result.The urine sample the patient brought from home was run on meter b with a positive result (50 ery/ul).The customer was not sure which result was correct.

Manufacturer Narrative

The test strips were stored at room temperature in the original sealed vial.The strips had no visible discoloration.The strip was used immediately after removing it from the vial.Controls were run on each meter with passing results.Each meter was calibrated properly.The customer stated the test strip is placed with the pads facing upwards but the customer was not able to confirm if each clinician is pushing the strip below the clip as far as it will go.Meter a and meter c and the test strips were requested for investigation.The retention material of lot 64616800 was checked by visual reading with 0-native-urine and a blood dilution.The retention material of lot 64616800 was measured on a urisys1100 analyzer used at the investigation site with 0-native urine and a blood dilution.The results of all measurements fulfill the requirements.No abnormal results were observed.The investigation is ongoing.Device evaluated by mfr : na.

Manufacturer Narrative

Meters a (ux09641834) and c (ux09638953) along with two vials of strip lot 64616808 were received for investigation.Sections d9 and h3 were updated.All materials show no signs of damage or abnormalities.The retention material of lot 64616800 and the customer materials of lot 64616808 were measured on a urisys 1100 analyzer used at the investigation site and the customer's urisys 1100 analyzers with 0-native-urine and a blood dilution series.The results of all measurements fulfill the requirements.No abnormal results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16555575
• MDR Text Key: 311575726
• Report Number: 1823260-2023-00834
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• 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