MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-07 for ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR ADVIA CHEMISTRY A1C_3 CALIBRATOR 10491408 manufactured by Siemens Healthcare Diagnostics Inc..
[4818155]
The customer has observed high bias on cap survey samples on an advia 1800 instrument when using calibrator lot 3hd044 and reagent lot 140. The first two samples showed high bias compared to the expected value. There were no reports of patient intervention or adverse health consequences due to the high bias observed on the cap samples for the a1c_3 assay.
Patient Sequence No: 1, Text Type: D, B5
[12375506]
Siemens has confirmed that the advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. Depending on quality control limits, this issue may not have been detected. An urgent medical device recall (umdr) 10819262, rev. A was sent to us customers and an urgent field safety notice (ufsn) 10819261, rev. A was sent to ous customers in august of 2014. The umdr and ufsn state that customers are requested to discontinue use of and discard the calibrator lots listed, and to review the physician's letter sent along with the umdr and ufsn with their medical director.
Patient Sequence No: 1, Text Type: N, H10
[32154501]
The original mdr 2432235-2014-00437 was filed on august 7, 2014. Corrected information (08/25/14): updated with the correct 510k number k081895.
Patient Sequence No: 1, Text Type: N, H10
[32158139]
The original mdr 2432235-2014-00437 was filed on august 7, 2014. The first follow up report was filed on september 3, 2014. Additional information (12/19/14): final root cause: bias in patient sample and (b)(4) survey performance was not detected due to the insensitivity in the calibrator and reagent testing control system. The overall capability (error budget) of a1c_3 method was not sufficient to consistently provide clinically acceptable results across all reagent and calibrator lots. A key component of the error budget is the manufacturing controls system for assignment of the calibrator bottle values where the inaccuracy of this process is due to lack of statistical power.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00437 |
| MDR Report Key | 3986405 |
| Report Source | 05,06 |
| Date Received | 2014-08-07 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-05-19 |
| Date Mfgr Received | 2014-12-19 |
| Date Added to Maude | 2014-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 2517506) |
| Manufacturer Street | 500 GBC DRIVE P.O. BOX 6101 |
| Manufacturer City | NEWARK DE 19714610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 6101 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-08/04/14-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR |
| Generic Name | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR |
| Product Code | PDJ |
| Date Received | 2014-08-07 |
| Model Number | ADVIA CHEMISTRY A1C_3 CALIBRATOR |
| Catalog Number | 10491408 |
| Lot Number | 3HD044 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-07 |