MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ALBUSTIX REAGENT STRIPS

Model Number	10333485
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested the albustix to be returned for investigation.The cause of this event is unknown.
Event or Problem Description
A pharmacist reported that a patient tested their morning urine sample with two different lots of albustix for protein and the results were negative.Later that afternoon, the patient had a new urine sample run in the laboratory and the protein result was 2+.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has completed the investigation.Testing was completed on the 6 strips from lot# 003022 and 18 strips from lot# 005068 to evaluate the returned albustix.Strips were dipped into a contrived solution.This contrived solution is used to test at an expected protein concentration of 30 mg/dl.Readings were taken visually under lighting from a light box at 60 seconds measured with a calibrated timer.Colors were compared to the color chart on the supplied bottle.A total of 24 results were obtained and recorded using the designated concentration from the bottle.All results were at the expected 30 mg/dl concentration level.Based on the data collected, the customer report of false negative protein results while using albustix for testing, as reported in gsms pm00267911, was not observed.

• Brand Name: ALBUSTIX REAGENT STRIPS
• Common Device Name: ALBUSTIX
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11396276
• Report Number: 3002637618-2021-00009
• Device Sequence Number: 1283532
• Product Code: JIR
• UDI-Device Identifier: 00630414550602
• UDI-Public: 00630414550602
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K992257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10333485
• Device Catalogue Number: 10333485
• Device Lot Number: 003022
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1