POCcelerator™ Data Management System 10732871Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414208275), received between Jan 6, 2026 and Aug 31, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523481 ↗MalfunctionJan 6, 2026Patient Data Problem
THE CUSTOMER HAS REPORTED MULTIPLE OCCURRENCES OF A DEVICE OPERATOR SCANNING THEIR OPERATOR ID BADGE FOR THE PATIENT ID AT TIME OF TESTING, WHICH HAS RESULTED IN THE TEST RESULTS POSTING TO THE INCORRECT PATIENT'S CHART. THE CUSTOMER STATED THAT THE ERROR WAS EASILY IDENTIFIABLE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980716 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.