MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-28 for ADVIA 2120I WITH AUTOSAMPLER 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[2589617]
A discordant low hemoglobin (hgb) result was obtained with one (1) patient sample on an advia 2120i analyzer. The discordant low hgb result was reported to the physician. The low result was not questioned, and the sample was not retested. The patient was subsequently transfused with two (2) units of packed red blood cells. Five days later, a new sample was drawn post-transfusion, and the results were higher. Six days after the initial low result was obtained, the laboratory ran hgb testing on another tube from the patient's initial blood draw (a tube which had been collected for hgb a1c testing). The hgb result from the other tube was within the normal range. The qc results were within range on the day the initial low hgb result was obtained. (b)(4) 2012: additional information received: the customer claimed that only one tube was drawn from the patient, not two, as initially stated above. The customer claimed that the one tube was initially run for hgb on (b)(6) 2012 under sid (b)(4), and was not repeated that day. The customer claimed that on (b)(6) 2012, an additional barcode label was affixed to the original tube drawn on (b)(6) 2012 in order to run hemoglobin a1c testing from the tube. The customer explained that the additional barcode label obscured the original sid of the tube.
Patient Sequence No: 1, Text Type: D, B5
[9897422]
The customer contacted the siemens technical solutions center (tsc) regarding this event. The cause of the discordant hemoglobin result is unknown. No conclusions can be drawn as to what specifically caused the discordant low hemoglobin result.
Patient Sequence No: 1, Text Type: N, H10
[22041689]
A discordant low hemoglobin (hgb) result was obtained with one (1) patient sample on an advia 2120i analyzer. The discordant low hgb result was reported to the physician. The low result was not questioned, and the sample was not retested. The patient was subsequently transfused with two (2) units of packed red blood cells. Five days later, a new sample was drawn post-transfusion, and the results were higher. Six days after the initial low result was obtained, the laboratory ran hgb testing on another tube from the patient's initial blood draw (a tube which had been collected for hgb a1c testing). The hgb result from the other tube was within the normal range. The qc results were within range on the day the initial low hgb result was obtained.
Patient Sequence No: 1, Text Type: D, B5
[22200623]
The customer contacted the siemens technical solutions center (tsc) regarding this event. The cause of the discordant hemoglobin result is unknown. No conclusions can be drawn as to what specifically caused the discordant low hemoglobin result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00058 |
| MDR Report Key | 2471696 |
| Report Source | 05,06 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-23 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-23 |
| Device Manufacturer Date | 2010-02-20 |
| Date Added to Maude | 2012-08-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BARBARA KVASNOSKY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243658 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I WITH AUTOSAMPLER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-02-28 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-02-28 |