MAUDE Adverse Event Report: ACON LABORATORIES, INC. MCKESSON CONSULT 120 URINE ANALYZER

Lot Number 160714

Device Problem False Negative Result (1225)

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

Event Date 09/17/2019

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2019 that the urine analyzer is giving false negative results but when read visually, the results are coming up positive.Reportedly, the analyzer is a few years old.When the reporter ran the sample on the analyzer, it read negative for leuks but the same sample when read visually with a new strip showed 1+ results.The sample was read at the correct visual read time.No additional patient or event information is available.The product was returned for evaluation.A supplemental report will be submitted once the investigation is complete.

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the device evaluation was completed: b5: describe event or problem - additional information and device evaluation.D4: lot number - additional information.H2: additional information and device evaluation.H3: device evaluated by manufacturer - additional.H6: method code - additional.H6: results code - additional.H6: conclusion code - additional.

Event Description

The product was returned for evaluation.Review of the manufacturing and qc records indicate that the analyzer was manufactured without issue and met all the product release criteria.The returned analyzer and strips were tested with diluted control solutions and clinical urine samples.The tests were compared to a new canister of mckesson strips and siemens strips.The results for both the analyzer results and the visual showed no anomalies.No false negatives were observed.The led status of the returned analyzer was also observed to be within the acceptable range set up i.E.2347/2503.As the returned products did not reproduce the reported issue, the root cause could not be determined.The reported issue of getting false negatives results on the analyzer could not be confirmed.

• Brand Name: MCKESSON CONSULT 120 URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego CA 92121
• MDR Report Key: 9188701
• MDR Text Key: 192043169
• Report Number: 2531491-2019-00003
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10612479210278
• UDI-Public: (01)10612479210278
• Combination Product (y/n): N
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 160714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1