MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U PACK; URINE TEST STRIP

Catalog Number 06334601001

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter tried removing the cobas u pack manually, but could not do it.The reporter later noted that they had installed a damaged cobas u pack by mistake.The reporter later was able to remove this pack and the analyzer was working after this.The affected cobas u pack was thrown in the trash.Phone number was provided as (b)(6).This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant nitrite results for an unspecified number of patient samples tested with a cobas u pack on a cobas u 601 urine analyzer.Incorrect results were reported outside of the laboratory.The analyzer also indicated there was an error with the cobas u pack.The reporter stated she ran quality control material and patient samples and all resulted with positive values for nitrite.The reporter repeated the patient samples and control and received negative nitrite values.The reporter believes all patient samples and control were initially false positive.The u 601 analyzer serial number is (b)(4).

Manufacturer Narrative

The investigation was unable to determine a root cause.

• Brand Name: COBAS U PACK
• Type of Device: URINE TEST STRIP
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10058243
• MDR Text Key: 204249545
• Report Number: 1823260-2020-01226
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K183432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06334601001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1