MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION(R) CLINICAL CHEMISTRY SYSTEM; HEMOGLOBIN A1C KIT

Catalog Number DF105A

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 02/18/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discordant (b)(6) results is a reagent storage excursion.After repeating samples, a technician stated that the laboratory's reagent refrigerator had changed temperature dramatically to -17c and then went up to room temperature.The technician noticed that some of the reagents were frozen.(b)(6) lot ga5314 was in the laboratory's refrigerator at the time of the temperature fluctuation.That lot was discarded and a new lot shipment, (that was not in that refrigerator until after repairs) was placed on the instrument.No further issues were observed.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant (b)(6) results were obtained on patient samples.The result of at least one of the patients was reported to the physician who questioned the result.The samples were repeated with an alternate lot of reagent and concordant results were obtained.A corrected result was reported on the one patient previously reported.It is unknown if patient treatment was altered or prescribed on the basis of the discordant (b)(6) results.There was no report of adverse health consequences as a result of the discordant (b)(6) results.

• Brand Name: DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
• Type of Device: HEMOGLOBIN A1C KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5336023
• MDR Text Key: 34764834
• Report Number: 2517506-2015-00216
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 11/10/2015
• Device Catalogue Number: DF105A
• Device Lot Number: GA5314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1