MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-12 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc..
[77567792]
The customer performed an investigation and determined that sample id (b)(6) may have been sampled instead of sample id (b)(6). The cause of the incorrect results being obtained on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[77567793]
The customer contacted a siemens customer care center and stated that sample ids (b)(6) were placed on a streamlab? Analytical workcell system and sample id (b)(6) came back with results that matched the results obtained on sample id (b)(6). The patient for sample id (b)(6) was tested earlier in an emergency room at a different location and then sent to the customer site for enzyme testing. The customer repeated the same tests as those performed in the emergency room along with the enzymes. The customer reported the results to the emergency room physician(s), who questioned the results as they did not match. The customer repeated the sample in duplicate on the original and alternate dimension vista instruments by front loading the sample. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the incorrect results being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00527 |
| MDR Report Key | 6633593 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-12 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-06-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | 10040 VAL DELLA TORRE (TORINO), |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREAMLAB? ANALYTICAL WORKCELL |
| Generic Name | STREAMLAB? ANALYTICAL WORKCELL |
| Product Code | LGX |
| Date Received | 2017-06-12 |
| Model Number | STREAMLAB? ANALYTICAL WORKCELL |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-12 |