MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-7-TEST 100 STR.; URINE TEST STRIPS

Model Number U1100

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient urine sample tested for nitrites on urisys 1100 analyzer serial number (b)(4).The erroneous results were reported outside of the laboratory.The sample initially resulted with a positive nitrite value.The sample was repeated and the nitrite value was again positive.The sample was repeated a second time and the nitrite value was negative.The negative value was considered to be ok.No adverse events were alleged to have occurred with the patient.The customer uses combur 7 test strips.The lot number and expiration date of the test strips were asked for, but not provided.The customer suspects that the test strips may have been incorrectly positioned in the analyzer when the test strips were measured.The analyzer appeared to be clean and there were no obvious deposits or debris.

Manufacturer Narrative

The test strip lot number was 17822901, with an expiration date of 28-feb-2018.

Manufacturer Narrative

Retention test strip material (lot 178229) was tested with a retention urisys 1100 analyzer using native urine, and a leukocyte, protein, and nitrite dilution series.The results of all measurements fulfilled requirements.No false negative or implausible results were observed.One vial of the customer's test strip lot number 17822901 was provided for investigation.The test strips showed discoloration on different test pads.Investigation measurements of the provided test strips was not possible because of the discoloration.The customer's test strips show a typical error pattern caused by humidity.Update: unique identifier (udi)# = (b)(4).

• Brand Name: COMBUR-7-TEST 100 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7334067
• MDR Text Key: 102228092
• Report Number: 1823260-2018-00808
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

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: Nurse
• Device Expiration Date: 02/28/2018
• Device Model Number: U1100
• Device Catalogue Number: 11008552191
• Device Lot Number: 17822901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/26/2018; 02/26/2018
• Supplement Dates FDA Received: 03/27/2018; 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1