MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+

Catalog Number 10379676

Device Problem False Negative Result (1225)

Patient Problem Intermenstrual Bleeding (2665)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has advised the customer that per the reagent ifu, "urine hcg concentrations are approximately one-half of, or less than one-half, of corresponding serum hcg concentrations" and "hormone levels greater than 25 miu/ml are reported as positive." therefore the negative result received on 4/27 was a valid result.No urinalysis was run on the sample in question and the customer is unsure of the cleanliness of the instrument at the time of the discrepancy.The customer has agreed to return their instrument to the siemens workshop for repair and investigation.The workshop ran the instrument on the automated test equipment and it failed with a "clean calstrip" message.A splash was cleaned off of the calibration bar and the instrument passed all subsequent testing.The cause of the event was due to improper maintenance.

Event Description

The customer reported that they received two false negative hcg results on a single patient who was suspected of having had a miscarriage.The first result was compared to serum hcg testing and an ultrasound and the second was received a week later compared to serum hcg testing and follow up urine testing on another clinitek status+ the next day.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 11970488
• MDR Text Key: 257467731
• Report Number: 3002637618-2021-00037
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1