MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number DIMENSION RXL MAX WITH HM

Device Problem False Negative Result (1225)

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

Event Date 05/19/2015

Event Type  malfunction  

Event Description

A discordant, false negative human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension rxl max with hm instrument.The discordant result was reported to the physician(s).The physician performed an ultrasound and the patient was confirmed to be pregnant.The sample was manually diluted and re-run on the same instrument, resulting positive for hcg.A new sample obtained from the patient was tested on the instrument, resulting with an unbelievable result.The sample was manually diluted and repeated, resulting positive for hcg.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, false negative hcg results.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).It was discovered that the discordant hcg results were obtained on an expired calibration and hcg level 1 quality control was out of range.The cause of the discordant hcg results is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 1226181-2015-00382 was filed on june 23, 2015.Additional information (06/24/2015): a siemens headquarter support center (hsc) specialist reviewed the instrument data.Hsc concluded that the auto-dilution function will not perform on an expired calibration.The customer was running the samples on an expired calibration for the dimension hcg method, and results flagged with a "high a error", indicating that an auto-dilution was not performed.The cause of the discordant, false negative hcg results being reported to the physician(s) was due to user error.The instrument is performing according to specifications.No further evaluation of the device is required.(b)(4).

• Brand Name: HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 610
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration: 2517506; newark DE 19714 610
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 4863636
• MDR Text Key: 5865987
• Report Number: 1226181-2015-00382
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION RXL MAX WITH HM
• Device Lot Number: DA5346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1