MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-28 for DIMENSION? DF207 SMN10700795 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[63411976]
The customer contacted the siemens customer care center (ccc). The cause of the discordant, low tac results is unknown. The account discontinued the tac dosage on the basis of the higher results obtained by the alternate methodology, lc/ms. Although there was an indication that some renal dysfunction had occurred, the latest update from the account is that the status of the patient is improving. Siemens headquarters support center is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[63411977]
Discordant, low tacrolimus (tac) results were obtained on one patient's samples on the dimension xpand plus instrument. The results were reported to the physician. The samples was retested by an alternate methodology (lcms) and higher results were obtained. The patient tacrolimus dosage was increased on the basis of the initial low results. There was some indication that renal dysfunction occurred due to the increase of dosage.
Patient Sequence No: 1, Text Type: D, B5
[67460171]
The siemens healthcare diagnostics headquarters support center (hsc) has evaluated the information provided by the customer and examined the instrument log data for the discordant low tacrolimus (tac) results. The customer laboratory reported that the issue was isolated to this individual pediatric patient's samples and not samples from other patients. No instrument issues were reported or observed in the instrument log data. Some sample handling issues were observed in the instrument log data, however they could not be correlated with the reported issue. The customer stated that this pediatric patient's samples were collected in 3 ml ethylenediaminetetraacetic acid (edta) tubes. The tubes were consistently underfilled with approximately 1 ml of blood. The volume was estimated, not measured, and could be 0. 5 to 1 ml. Under filling edta tubes increases the concentration of edta in the aliquot of whole blood tested for tac. Increased concentrations of edta cause falsely low tac values. The tac ifu states the non-interference level of edta is 3 mg/ml. This value is higher than the concentration in commercially available collection tubes unless they are under filled. Collection tube edta concentration is approximately 1. 8 mg/ml for an appropriately filled collection tube. Edta concentrations exceeding 3 mg/ml will depress tac results. A collection tube with 0. 5 to 1 ml of blood collected would have a edta concentration in the range of 5. 4 to 10. 8 mg/ml. The dimension? Tacrolimus flex? Reagent cartridge (tac) instructions for use states: follow the instructions provided with your specimen collection device for use and processing. Whole blood can be collected using recommended procedures for collection of diagnostic blood specimens by venipuncture. The final conclusion from siemens is that the product was performing as designed at the time of testing. Falsely low tac (tacrolimus) values were consistently obtained on one pediatric patient due to phlebotomist under filling of the patient's edta collection tubes during blood collection. As of 2/6/2017 the customer reported further information on the status of the patient. They stated that after stopping the administration of tacrolimus, the 10 month old blood tumor patient became a complete remission and was discharged from the hospital. In addition, the customer provided information that the samples were collected via the line connected to a peripheral central venous catheter.
Patient Sequence No: 1, Text Type: N, H10
[72997506]
Initial mdr was filed on 12/28/2016. Supplement 1 was filed on 2/10/2017. Update - siemens healthcare diagnostics has obtained corrected information after we requested additional clarification from our regional unit in (b)(4) on 3/13/2017. Requested clarification was received between 3/13/2017 and 3/17/2017 the following information provided in the original mdr (see below) was incorrect. From initial mdr - tacrolimus results (b)(6) 2016 (ng/ml), initial result, (sample 1): less than 0. 1 ng/ml, tacrolimus dosage was increased. Result on new sample (sample 2): 5 ng/ml. The field engineer could not confirm the dates that the results above were obtained and the sample identification numbers originally provided as sample 1 and sample 2 from (b)(6) 2016 in the original mdr. The regional unit has provided the following confirmed sample identification numbers (sids), dates of testing, and results from this patient: (b)(6). Correction from previous information - the patient tacrolimus dosage was increased on (b)(6) 2016 and then again on (b)(6) 2016. Tacrolimus dosing was discontinued (b)(6) 2016. In addition the field engineer could not confirm the sid number for sample 1 that was tested by lc/ms in the initial information submitted in the original mdr. They were able to define that sample 2 that was tested by lcms on (b)(6) 2016 was (b)(6). The results on the lc/ms were regarded as correct by the physician. Per information provided by the edta tube manufacturer customer support department, the edta tube contained liquid solution. The edta tube contains 50 microliters of a 15%w/v liquid solution of edta-3k. 2h2o. Siemens headquarters support center is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2016-00561 |
| MDR Report Key | 6210199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-28 |
| Date of Report | 2018-03-15 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2016-07-05 |
| Date Added to Maude | 2016-12-28 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? TACROLIMUS (TAC) FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2016-12-28 |
| Catalog Number | DF207 SMN10700795 |
| Lot Number | FA7186 |
| Device Expiration Date | 2017-07-05 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-28 |