MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE; DIMENSION VISTA® CA FLEX® REAGENT CARTRIDGE

Catalog Number K1023 SMN 10445160

Device Problem Low Test Results (2458)

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

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discrepant low ca results is related to a flex reagent cartridge well set issue.The low results were obtained from a single well set 12:6.Siemens healthcare diagnostics has completed an investigation of calcium (ca) flex® reagent cartridge lot 16060bb.It has been confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 16060bb may produce erroneously low results from specific well sets.If calibration is performed using an unaffected well set and samples are subsequently run using an affected well set, ca results may be falsely depressed up to -2.9 mg/dl (-0.72 mmol/l).Bias for serum, plasma, and urine specimens are similar.If calibration is performed using an affected well set, ca results for patient and qc samples from subsequent unaffected well sets may be falsely elevated.An urgent medical device recall communication, vc-16-05.A.Us, and an urgent field safety notice, vc-16-05.A.Ous dated august 9, 2016 was issued to customers who had been shipped lot 16060bb.Customers were instructed to discontinue use and to discard the lot.Siemens offered a no charge replacement for discarded reagent.The account was shipped an alternate ca lot.

Event Description

Falsely depressed calcium (ca) results were obtained on qc and patient samples on the dimension vista instrument.Patient results were reported.After the qc was detected outside of laboratory ranges, patient samples were retested on an alternate reagent cartridge and higher results were recovered.Corrected reports were issued.The discrepant results were obtained from one flex reagent well set.There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed ca results.There was no report of adverse health consequences as a result of the falsely depressed ca results.

• Brand Name: DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION VISTA® CA FLEX® REAGENT CARTRIDGE
• 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: 5888317
• MDR Text Key: 52495642
• Report Number: 2517506-2016-00295
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 16060BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-08-15-2016-002-R
• Patient Sequence Number: 1