MAUDE Adverse Event Report: TOSOH AIA, INC. TOSOH ST AIA-PACKS, MULTIPLE ANALYTES

Catalog Number MULTIPLE

Device Problem Inadequate Storage (1600)

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

Event Date 02/04/2015

Event Type  Injury  

Event Description

(b)(6) 2015 a tosoh bioscience field service engineer was at a customer site to do annual preventive maintenance on the tosoh aia-900 analyzer.He noted that the tosoh reagents used for testing various analytes were not stored at 2-8 degree c when not in use.The storage temperature info for the tosoh reagents is indicated on the reagent boxes and the instructions for use.Stability of the reagents is unk when stored for extended periods of time at room temperature, which could result in unreliable analyte results.

• Brand Name: TOSOH ST AIA-PACKS, MULTIPLE ANALYTES
• Type of Device: MULTIPLE
• Manufacturer (Section D): TOSOH AIA, INC.; 2, iwase koshi-machi; toyama 931- 8510; JA 931-8510
• Manufacturer (Section G): TOSOH AIA, INC.; 2, iwase koshi-machi; toyama 9318 510; JA 9318510
• Manufacturer Contact: susan koss ; 3600 gantz road; grove city, OH 43123 ; 6143171909
• MDR Report Key: 4505899
• MDR Text Key: 5406319
• Report Number: 3005529799-2015-00002
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MULTIPLE
• Device Lot Number: MULTIPLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2015
• Distributor Facility Aware Date: 02/04/2015
• Event Location: Outpatient Diagnostic Facility
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE INDICATED.
• Patient Outcome(s): Other