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

Catalog Number 03260763160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

The customer received a questionable nitrate result for one patient urine sample from urisys 1100 analyzer serial number (b)(4).The initial result was positive for nitrate.The sample was sent to the hospital laboratory and the result was negative.The erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.Replacement product was sent.The retention material of lot #32223100 was measured on an iu urisys 1100 with native urine and a nitrite-dilution-series.The results of the measurements fulfill the requirements.No false positive results were observed.

Manufacturer Narrative

The customer material has been visually checked and showed no abnormalities or signs of discoloration.The customer material of lot 32223101 was measured on an iu urisys 1100 with native urine and a nitrite dilution series.The results of the measurements fulfill the requirements.No false positive 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
• MDR Report Key: 8150041
• MDR Text Key: 130633375
• Report Number: 1823260-2018-04750
• 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: 01/25/2019

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: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1