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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2 TINA-QUANT ALBUMIN GEN.2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

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ROCHE DIAGNOSTICS ALBT2 TINA-QUANT ALBUMIN GEN.2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 04469658190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2024
Event Type  malfunction  
Manufacturer Narrative
The c501 analyzer serial number is (b)(6).The investigation is ongoing.
 
Event Description
The initial reporter stated they received discrepant results for two patient urine samples tested with albt2 tina-quant albumin gen.2 on a cobas 6000 c501 module.The first sample initially resulted in a microalbumin value of 6.76 mg/dl and it repeated as 0.35 mg/dl.The field service engineer checked the gear pump pressure, the probe, and probe dispensing.The probes were cleaned and adjustments were checked.The wash station and tubing integrity were also checked.The lamp and cuvettes were replaced.On (b)(6) 2024, the customer encountered the issue again with a second sample.This second sample initially resulted in a microalbumin value of 11.26 mg/dl.The sample was repeated twice, resulting in values of 0.76 mg/dl and 0.13 mg/dl.
 
Manufacturer Narrative
Quality control data showed imprecision with out of range high results.The field service engineer replaced the sample probe and rinse tubing.The probe was adjusted and the gear pump pressure was checked.The cells and lamps were replaced.The investigation determined the service actions (probe and tubing replacement) resolved the issue.
 
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Brand Name
ALBT2 TINA-QUANT ALBUMIN GEN.2
Type of Device
ALBUMIN IMMUNOLOGICAL TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
ibaraki 312-8 504
JA   312-8504
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250-0457
MDR Report Key18818738
MDR Text Key337427168
Report Number1823260-2024-00628
Device Sequence Number1
Product Code DCF
Combination Product (y/n)Y
Reporter Country CodeIT
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/13/2024
2 Devices were Involved in the Event: 1   2  
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 Catalogue Number04469658190
Device Lot Number758117
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer Received03/13/2024
Supplement Dates FDA Received03/13/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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