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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS COMBUR-7-TEST 100 STR.; URINE TEST STRIPS Back to Search Results
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).
 
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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 Key7334067
MDR Text Key102228092
Report Number1823260-2018-00808
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
PMA/PMN Number
K032437
Number of Events Reported1
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 Date02/28/2018
Device Model NumberU1100
Device Catalogue Number11008552191
Device Lot Number17822901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Initial Date Manufacturer Received 02/26/2018
Initial Date FDA Received03/13/2018
Supplement Dates Manufacturer Received02/26/2018
02/26/2018
Supplement Dates FDA Received03/27/2018
04/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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